RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>69238-2122-9</NDCCode>
    <PackageDescription>237 mL in 1 BOTTLE (69238-2122-9) </PackageDescription>
    <NDC11Code>69238-2122-09</NDC11Code>
    <ProductNDC>69238-2122</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisolone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Prednisolone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221027</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216715</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisolone sodium phosphate oral solution is indicated in the following conditions:. 1. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases. For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System. Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases. Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases. Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. Rheumatic Disorders. As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).</IndicationAndUsage>
    <Description>Prednisolone sodium phosphate oral solution is a dye free, pale to yellow grape flavored solution. Each 5 mL (teaspoonful) of prednisolone sodium phosphate oral solution contains 20.2 mg prednisolone sodium phosphate, USP (15 mg prednisolone, USP base) in a palatable, aqueous vehicle. Prednisolone sodium phosphate oral solution (15 mg prednisolone per 5 mL) contains the following inactive ingredients: edetate disodium, fructose, glycerin, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, sodium saccharin, bitter masker flavor, grape type flavor. Prednisolone sodium phosphate, USP occurs as white to almost white powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate, USP is:11β,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-(disodium phosphate). The molecular formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid.</Description>
  </NDC>
  <NDC>
    <NDCCode>11770-2122-1</NDCCode>
    <PackageDescription>.42 kg in 1 BOTTLE (11770-2122-1) </PackageDescription>
    <NDC11Code>11770-2122-01</NDC11Code>
    <ProductNDC>11770-2122</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20210331</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>DDP Specialty Electronic Materials US 9, LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAR-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11770-2122-2</NDCCode>
    <PackageDescription>18 kg in 1 PAIL (11770-2122-2) </PackageDescription>
    <NDC11Code>11770-2122-02</NDC11Code>
    <ProductNDC>11770-2122</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20210331</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>DDP Specialty Electronic Materials US 9, LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAR-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11770-2122-3</NDCCode>
    <PackageDescription>200 kg in 1 DRUM (11770-2122-3) </PackageDescription>
    <NDC11Code>11770-2122-03</NDC11Code>
    <ProductNDC>11770-2122</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20210331</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>DDP Specialty Electronic Materials US 9, LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAR-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11770-2122-4</NDCCode>
    <PackageDescription>950 kg in 1 CONTAINER (11770-2122-4) </PackageDescription>
    <NDC11Code>11770-2122-04</NDC11Code>
    <ProductNDC>11770-2122</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20210331</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>DDP Specialty Electronic Materials US 9, LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAR-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-2122-9</NDCCode>
    <PackageDescription>16 TABLET in 1 BOTTLE (71335-2122-9) </PackageDescription>
    <NDC11Code>71335-2122-09</NDC11Code>
    <ProductNDC>71335-2122</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208412</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets USP are indicated in the following conditions.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains. Prednisone, USP.................................................. 10 mg, 20 mg and 50 mg. Inactive Ingredients. The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. Prednisone tablets USP contain prednisone USP, which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>61957-2122-1</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (61957-2122-1)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>61957-2122-01</NDC11Code>
    <ProductNDC>61957-2122</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diorskin Nude Air Nude Healthy Glow Ultra-fluid Serum Foundation With Sunscreen Broad Spectrum Spf25</ProprietaryName>
    <ProprietaryNameSuffix>021 Linen</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141012</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Parfums Christian Dior</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>74.9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( , decreases the risk of skin cancer and early skin aging caused by the sun. see ) Directions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69238-1050-9</NDCCode>
    <PackageDescription>2 BOTTLE in 1 BLISTER PACK (69238-1050-9)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
    <NDC11Code>69238-1050-09</NDC11Code>
    <ProductNDC>69238-1050</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209716</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</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>Deprecated</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69238-1108-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1108-9) </PackageDescription>
    <NDC11Code>69238-1108-09</NDC11Code>
    <ProductNDC>69238-1108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clomipramine Hcl</ProprietaryName>
    <NonProprietaryName>Clomipramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208632</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is.                             C19H23ClN2 ● HCl                   MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1109-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1109-9) </PackageDescription>
    <NDC11Code>69238-1109-09</NDC11Code>
    <ProductNDC>69238-1109</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clomipramine Hcl</ProprietaryName>
    <NonProprietaryName>Clomipramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208632</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is.                             C19H23ClN2 ● HCl                   MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1110-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1110-9) </PackageDescription>
    <NDC11Code>69238-1110-09</NDC11Code>
    <ProductNDC>69238-1110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clomipramine Hcl</ProprietaryName>
    <NonProprietaryName>Clomipramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208632</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e. for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clomipramine hydrochloride (HCl) capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is.                             C19H23ClN2 ● HCl                   MW = 351.31. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 50 mg capsule shell contains: D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The 75 mg capsule shell contains: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1123-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1123-9) </PackageDescription>
    <NDC11Code>69238-1123-09</NDC11Code>
    <ProductNDC>69238-1123</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208832</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
    <Description>Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4                  MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1124-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1124-9) </PackageDescription>
    <NDC11Code>69238-1124-09</NDC11Code>
    <ProductNDC>69238-1124</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208832</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
    <Description>Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4                  MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1125-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1125-9) </PackageDescription>
    <NDC11Code>69238-1125-09</NDC11Code>
    <ProductNDC>69238-1125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208832</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
    <Description>Nadolol tablets, USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula. C17H27NO4                  MW 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, maize starch, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1146-9</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1146-9) </PackageDescription>
    <NDC11Code>69238-1146-09</NDC11Code>
    <ProductNDC>69238-1146</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin</ProprietaryName>
    <NonProprietaryName>Rosuvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208850</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&amp;C Blue No. 2, FD&amp;C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&amp;C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&amp;C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1147-9</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1147-9) </PackageDescription>
    <NDC11Code>69238-1147-09</NDC11Code>
    <ProductNDC>69238-1147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin</ProprietaryName>
    <NonProprietaryName>Rosuvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208850</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&amp;C Blue No. 2, FD&amp;C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&amp;C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&amp;C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1148-9</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1148-9) </PackageDescription>
    <NDC11Code>69238-1148-09</NDC11Code>
    <ProductNDC>69238-1148</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin</ProprietaryName>
    <NonProprietaryName>Rosuvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208850</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&amp;C Blue No. 2, FD&amp;C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&amp;C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&amp;C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1149-9</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1149-9) </PackageDescription>
    <NDC11Code>69238-1149-09</NDC11Code>
    <ProductNDC>69238-1149</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin</ProprietaryName>
    <NonProprietaryName>Rosuvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208850</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. .</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14 g/mol. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: FD&amp;C Blue No. 2, FD&amp;C Red No. 40, hypromellose, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition, the 5 mg tablet contains FD&amp;C Yellow No. 5 (tartrazine). In addition, the 10 mg, 20 mg and 40 mg tablets contain: FD&amp;C Yellow No. 6. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1154-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1154-9) </PackageDescription>
    <NDC11Code>69238-1154-09</NDC11Code>
    <ProductNDC>69238-1154</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208803</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
    <Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4- fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets, USP are available as a tablet for oral use containing 10 mg of ezetimibe, USP and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1155-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1155-9) </PackageDescription>
    <NDC11Code>69238-1155-09</NDC11Code>
    <ProductNDC>69238-1155</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1156-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1156-9) </PackageDescription>
    <NDC11Code>69238-1156-09</NDC11Code>
    <ProductNDC>69238-1156</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1157-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1157-9) </PackageDescription>
    <NDC11Code>69238-1157-09</NDC11Code>
    <ProductNDC>69238-1157</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1158-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69238-1158-9) </PackageDescription>
    <NDC11Code>69238-1158-09</NDC11Code>
    <ProductNDC>69238-1158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 80</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 2 As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1166-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1166-9) </PackageDescription>
    <NDC11Code>69238-1166-09</NDC11Code>
    <ProductNDC>69238-1166</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207482</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69238-1170-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1170-9) </PackageDescription>
    <NDC11Code>69238-1170-09</NDC11Code>
    <ProductNDC>69238-1170</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207482</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69238-1171-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1171-9) </PackageDescription>
    <NDC11Code>69238-1171-09</NDC11Code>
    <ProductNDC>69238-1171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207482</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69238-1172-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1172-9) </PackageDescription>
    <NDC11Code>69238-1172-09</NDC11Code>
    <ProductNDC>69238-1172</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207482</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69238-1173-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1173-9) </PackageDescription>
    <NDC11Code>69238-1173-09</NDC11Code>
    <ProductNDC>69238-1173</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207482</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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    <NDCCode>69238-1247-9</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1247-9) </PackageDescription>
    <NDC11Code>69238-1247-09</NDC11Code>
    <ProductNDC>69238-1247</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Memantine And Donepezil Hydrochlorides Extended-release</ProprietaryName>
    <NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208328</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>28; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-04</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
    <Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride, USP. The chemical name for memantine hydrochloride, USP is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21N HCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder. Donepezil Hydrochloride, USP. The chemical name for donepezil hydrochloride, USP is (±)-2-[(1-benzyl- 4-piperidyl) methyl]-5,6-dimethoxy-1-indanone hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.95. Donepezil hydrochloride, USP is off white to cream coloured powder. Memantine and donepezil hydrochlorides extended-release capsules contain 7 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (7 mg/10 mg), 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg), 21 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (21 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). Memantine and donepezil hydrochlorides extended-release capsules (7 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no. 10, FD&amp;C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and purified water. Memantine and donepezil hydrochlorides extended-release capsules (14 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no.10, FD&amp;C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, sodium hydroxide, propylene glycol, povidone, shellac and titanium dioxide. Memantine and donepezil hydrochlorides extended-release capsules (21 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no. 10, FD&amp;C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and purified water. Memantine  and donepezil hydrochlorides extended-release capsules (28 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no.10, FD&amp;C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
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    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-9) </PackageDescription>
    <NDC11Code>69238-1248-09</NDC11Code>
    <ProductNDC>69238-1248</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Memantine And Donepezil Hydrochlorides Extended-release</ProprietaryName>
    <NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208328</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>14; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
    <Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride, USP. The chemical name for memantine hydrochloride, USP is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21N HCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder. Donepezil Hydrochloride, USP. The chemical name for donepezil hydrochloride, USP is (±)-2-[(1-benzyl- 4-piperidyl) methyl]-5,6-dimethoxy-1-indanone hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.95. Donepezil hydrochloride, USP is off white to cream coloured powder. Memantine and donepezil hydrochlorides extended-release capsules contain 7 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (7 mg/10 mg), 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg), 21 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (21 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). Memantine and donepezil hydrochlorides extended-release capsules (7 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no. 10, FD&amp;C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and purified water. Memantine and donepezil hydrochlorides extended-release capsules (14 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no.10, FD&amp;C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, sodium hydroxide, propylene glycol, povidone, shellac and titanium dioxide. Memantine and donepezil hydrochlorides extended-release capsules (21 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no. 10, FD&amp;C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and purified water. Memantine  and donepezil hydrochlorides extended-release capsules (28 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&amp;C yellow no.10, FD&amp;C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
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