RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>64679-773-05</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-773-05) </PackageDescription>
    <NDC11Code>64679-0773-05</NDC11Code>
    <ProductNDC>64679-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091395</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.</IndicationAndUsage>
    <Description>Ropinirole extended-release tablet contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole extended-release tablets are formulated as film coated, circular shaped tablets with beveled edge. Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown), or 12 mg (green), respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole extended-release tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole extended-release tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole extended-release tablet 8 mg also contains iron oxide red and FD&amp;C blue # 2. Ropinirole extended-release tablet 12 mg also contains iron oxide yellow and FD&amp;C blue # 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-773-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-773-01) </PackageDescription>
    <NDC11Code>64679-0773-01</NDC11Code>
    <ProductNDC>64679-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091395</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.</IndicationAndUsage>
    <Description>Ropinirole extended-release tablet contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole extended-release tablets are formulated as film coated, circular shaped tablets with beveled edge. Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown), or 12 mg (green), respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole extended-release tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole extended-release tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole extended-release tablet 8 mg also contains iron oxide red and FD&amp;C blue # 2. Ropinirole extended-release tablet 12 mg also contains iron oxide yellow and FD&amp;C blue # 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-773-02</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-773-02) </PackageDescription>
    <NDC11Code>64679-0773-02</NDC11Code>
    <ProductNDC>64679-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091395</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.</IndicationAndUsage>
    <Description>Ropinirole extended-release tablet contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole extended-release tablets are formulated as film coated, circular shaped tablets with beveled edge. Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown), or 12 mg (green), respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole extended-release tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole extended-release tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole extended-release tablet 8 mg also contains iron oxide red and FD&amp;C blue # 2. Ropinirole extended-release tablet 12 mg also contains iron oxide yellow and FD&amp;C blue # 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-773-03</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-773-03) </PackageDescription>
    <NDC11Code>64679-0773-03</NDC11Code>
    <ProductNDC>64679-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091395</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.</IndicationAndUsage>
    <Description>Ropinirole extended-release tablet contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole extended-release tablets are formulated as film coated, circular shaped tablets with beveled edge. Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown), or 12 mg (green), respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole extended-release tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole extended-release tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole extended-release tablet 8 mg also contains iron oxide red and FD&amp;C blue # 2. Ropinirole extended-release tablet 12 mg also contains iron oxide yellow and FD&amp;C blue # 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-773-04</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (64679-773-04)  &gt; 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64679-0773-04</NDC11Code>
    <ProductNDC>64679-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091395</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.</IndicationAndUsage>
    <Description>Ropinirole extended-release tablet contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole extended-release tablets are formulated as film coated, circular shaped tablets with beveled edge. Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown), or 12 mg (green), respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole extended-release tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole extended-release tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole extended-release tablet 8 mg also contains iron oxide red and FD&amp;C blue # 2. Ropinirole extended-release tablet 12 mg also contains iron oxide yellow and FD&amp;C blue # 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-773-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (23155-773-05) </PackageDescription>
    <NDC11Code>23155-0773-05</NDC11Code>
    <ProductNDC>23155-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enalapril Maleate</ProprietaryName>
    <NonProprietaryName>Enalapril Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075479</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ENALAPRIL MALEATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension. Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets USP consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema).</IndicationAndUsage>
    <Description>Enalapril Maleate Tablets, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- [N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril Maleate Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&amp;C red #27 aluminum lake, D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1 aluminum lake, FD&amp;C red #40 aluminum lake, and FD&amp;C yellow #6 aluminum lake. Each 10 mg tablet contains FD&amp;C blue #2 aluminum lake, FD&amp;C red #40 aluminum lake and FD&amp;C yellow #6 aluminum lake. Each 20 mg tablet contains FD&amp;C yellow #6 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>55648-773-05</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-773-05)</PackageDescription>
    <NDC11Code>55648-0773-05</NDC11Code>
    <ProductNDC>55648-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091395</ApplicationNumber>
    <LabelerName>Wockhardt Limited</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Ropinirole Extended-release Tablet is an orally administered, non-ergoline dopamine agonist indicated for the treatment of signs and symptoms of idiopathic Parkinson’s disease. (1.1).</IndicationAndUsage>
    <Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is supplied as the hydrochloride salt of ropinirole 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has an empirical formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is:. Ropinirole hydrochloride is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole Extended-release Tablets are formulated as film coated, circular shaped tablets with beveled edge. Ropinirole Extended-release Tablets are available in 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown) and 12 mg (green). Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, and 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg, respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole Extended-release Tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole Extended-release Tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole Extended-release Tablet 8 mg also contains iron oxide red and FD&amp;C blue # 2. Ropinirole Extended-release Tablet 12 mg also contains iron oxide yellow and FD&amp;C blue # 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>60758-773-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60758-773-05)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60758-0773-05</NDC11Code>
    <ProductNDC>60758-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20131121</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021528</ApplicationNumber>
    <LabelerName>Pacific Pharma, Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.</IndicationAndUsage>
    <Description>Ketorolac tromethamine ophthalmic solution 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and its molecular weight is 376.40. Its molecular formula is C19H24N2O6 and it has the following structure:. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.4% solution, with a pH of approximately 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.4%. Preservative: benzalkonium chloride 0.006%. Inactives: edetate disodium 0.015%; octoxynol 40; purified water; sodium chloride; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-773-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (63304-773-05) </PackageDescription>
    <NDC11Code>63304-0773-05</NDC11Code>
    <ProductNDC>63304-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076045</ApplicationNumber>
    <LabelerName>SUN PHARMACEUTICAL INDUSTRIES INC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>63868-773-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63868-773-05) </PackageDescription>
    <NDC11Code>63868-0773-05</NDC11Code>
    <ProductNDC>63868-773</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19880524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075010</ApplicationNumber>
    <LabelerName>CHAIN DRUG MARKETING ASSOCIATION INC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19880524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: headachethe common coldmenstrual crampsbackachetoothache muscular achesminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68382-773-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (68382-773-05) </PackageDescription>
    <NDC11Code>68382-0773-05</NDC11Code>
    <ProductNDC>68382-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204331</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</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>2024-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170809</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 to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate.</Description>
  </NDC>
  <NDC>
    <NDCCode>82182-773-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82182-773-05)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>82182-0773-05</NDC11Code>
    <ProductNDC>82182-773</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220228</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021262</ApplicationNumber>
    <LabelerName>Pacific Pharma, Inc.</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>82907-773-05</NDCCode>
    <PackageDescription>5 g in 1 BOTTLE (82907-773-05) </PackageDescription>
    <NDC11Code>82907-0773-05</NDC11Code>
    <ProductNDC>82907-773</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Elamipretide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230908</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Hangzhou Sinodo Pharm Technology Co.,Ltd</LabelerName>
    <SubstanceName>ELAMIPRETIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>08-SEP-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>64679-101-05</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (64679-101-05)  &gt; 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (64679-101-08) </PackageDescription>
    <NDC11Code>64679-0101-05</NDC11Code>
    <ProductNDC>64679-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201331</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
    <Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&amp;C Blue No. 1 Lake, the 150-mg tablet contains FD&amp;C Blue No. 2 Lake and FD&amp;C Red No. 40 Lake, and the 200-mg tablet contains FD&amp;C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-102-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-102-05) </PackageDescription>
    <NDC11Code>64679-0102-05</NDC11Code>
    <ProductNDC>64679-102</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>(xl)</ProprietaryNameSuffix>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202189</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) (  1.2)  .</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, ethyl cellulose, eudragit L30D55, glyceryl behenate, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, shellac glaze, talc, titanium dioxide, triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 16.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-103-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-103-05) </PackageDescription>
    <NDC11Code>64679-0103-05</NDC11Code>
    <ProductNDC>64679-103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>(xl)</ProprietaryNameSuffix>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202189</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) (  1.2)  .</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, ethyl cellulose, eudragit L30D55, glyceryl behenate, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, shellac glaze, talc, titanium dioxide, triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 16.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-105-05</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (64679-105-05)  &gt; 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (64679-105-07) </PackageDescription>
    <NDC11Code>64679-0105-05</NDC11Code>
    <ProductNDC>64679-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201331</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
    <Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&amp;C Blue No. 1 Lake, the 150-mg tablet contains FD&amp;C Blue No. 2 Lake and FD&amp;C Red No. 40 Lake, and the 200-mg tablet contains FD&amp;C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-107-05</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (64679-107-05)  &gt; 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (64679-107-07) </PackageDescription>
    <NDC11Code>64679-0107-05</NDC11Code>
    <ProductNDC>64679-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201331</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
    <Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&amp;C Blue No. 1 Lake, the 150-mg tablet contains FD&amp;C Blue No. 2 Lake and FD&amp;C Red No. 40 Lake, and the 200-mg tablet contains FD&amp;C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-152-05</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (64679-152-05)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64679-0152-05</NDC11Code>
    <ProductNDC>64679-152</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090216</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir tablets, USP are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1). ●    Cold Sores (Herpes Labialis). ●    Genital Herpes. ●    Treatment in immunocompetent patients (initial or recurrent episode). ●    Suppression in immunocompetent or HIV-infected patients. ●    Reduction of transmission. ●    Herpes Zoster. Pediatric Patients ( 1.2). ●    Cold Sores (Herpes Labialis). ●    Chickenpox. Limitations of Use ( 1.3). ●    The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&amp;C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6- dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-153-05</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (64679-153-05)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64679-0153-05</NDC11Code>
    <ProductNDC>64679-153</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090216</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir tablets, USP are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1). ●    Cold Sores (Herpes Labialis). ●    Genital Herpes. ●    Treatment in immunocompetent patients (initial or recurrent episode). ●    Suppression in immunocompetent or HIV-infected patients. ●    Reduction of transmission. ●    Herpes Zoster. Pediatric Patients ( 1.2). ●    Cold Sores (Herpes Labialis). ●    Chickenpox. Limitations of Use ( 1.3). ●    The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&amp;C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6- dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-311-05</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (64679-311-05) </PackageDescription>
    <NDC11Code>64679-0311-05</NDC11Code>
    <ProductNDC>64679-311</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110528</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091267</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110528</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
    <Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is soluble in water and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-312-05</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (64679-312-05) </PackageDescription>
    <NDC11Code>64679-0312-05</NDC11Code>
    <ProductNDC>64679-312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110528</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091267</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110528</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
    <Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is soluble in water and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-374-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (64679-374-05)  &gt; 500 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>64679-0374-05</NDC11Code>
    <ProductNDC>64679-374</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090837</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64679-422-05</NDCCode>
    <PackageDescription>300 TABLET in 1 BOTTLE (64679-422-05) </PackageDescription>
    <NDC11Code>64679-0422-05</NDC11Code>
    <ProductNDC>64679-422</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078500</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1).</IndicationAndUsage>
    <Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: sodium starch glycolate, mannitol, microcrystalline cellulose, dibasic calcium phosphate anhydrous, colloidal silicon dioxide and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-433-05</NDCCode>
    <PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-433-05) </PackageDescription>
    <NDC11Code>64679-0433-05</NDC11Code>
    <ProductNDC>64679-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091231</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor (PPI) indicated for the following: 1   Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1) , 2   Maintenance of Healing of Erosive Esophagitis ( 1.2) , 3   Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (  1.3)  .</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water and practically insoluble in hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet for oral administration, available in two strengths (40 mg and 20 mg). Each delayed-release tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: aerosil 200, calcium stearate, colloidal silicon dioxide, mannitol, pregelatinized starch, shellac glaze, sodium carbonate anhydrous, sodium starch glycolate and talc. Each delayed-release tablet contains ammonium hydroxide, eudragit L 100-55, FD &amp; C Blue #2, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, propylene glycol, sodium hydroxide, titanium dioxide and triethyl citrate as the coating ingredients. Pantoprazole sodium delayed-release tablets USP, 20 mg and 40 mg, meet USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-434-05</NDCCode>
    <PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-434-05) </PackageDescription>
    <NDC11Code>64679-0434-05</NDC11Code>
    <ProductNDC>64679-434</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091231</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor (PPI) indicated for the following: 1   Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1) , 2   Maintenance of Healing of Erosive Esophagitis ( 1.2) , 3   Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (  1.3)  .</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water and practically insoluble in hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet for oral administration, available in two strengths (40 mg and 20 mg). Each delayed-release tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: aerosil 200, calcium stearate, colloidal silicon dioxide, mannitol, pregelatinized starch, shellac glaze, sodium carbonate anhydrous, sodium starch glycolate and talc. Each delayed-release tablet contains ammonium hydroxide, eudragit L 100-55, FD &amp; C Blue #2, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, propylene glycol, sodium hydroxide, titanium dioxide and triethyl citrate as the coating ingredients. Pantoprazole sodium delayed-release tablets USP, 20 mg and 40 mg, meet USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-447-05</NDCCode>
    <PackageDescription>15000 TABLET in 1 DRUM (64679-447-05) </PackageDescription>
    <NDC11Code>64679-0447-05</NDC11Code>
    <ProductNDC>64679-447</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078701</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine Tablets, USP are indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4  Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>The active ingredient in ranitidine tablets 150 mg and 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H 2-receptor antagonist. Chemically it is N[2-[[[5- [(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:. The empirical formula is C13H 22N4O3SHCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, crystalline practically odorless powder, very soluble in water, sparingly soluble in alcohol. Each ranitidine tablet 150 mg for oral administration contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hypromellose, titanium dioxide, diethyl phthalate, FD&amp;C yellow # 6 and iron oxide red. Each Ranitidine Tablet 300 mg for oral administration contains 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hypromellose, titanium dioxide, and diethyl phthalate.</Description>
  </NDC>
  <NDC>
    <NDCCode>64679-516-05</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (64679-516-05)  &gt; 30 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64679-0516-05</NDC11Code>
    <ProductNDC>64679-516</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078938</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>64679-544-05</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (64679-544-05)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64679-0544-05</NDC11Code>
    <ProductNDC>64679-544</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090367</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13), 9 Plague (1.14).</IndicationAndUsage>
    <Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin is a white to light yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3&gt;Cu+2&gt;Zn+2&gt;Mg+2&gt;Ca+2. Excipients and Description of Dosage Forms. Levofloxacin Tablets. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: : 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide,  hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol,  polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide., 2 500 mg (as expressed in the anhydrous form):  colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol,  sodium starch glycolate and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, hypromellose,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide.</Description>
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    <NDCCode>64679-545-05</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (64679-545-05)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64679-0545-05</NDC11Code>
    <ProductNDC>64679-545</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090367</ApplicationNumber>
    <LabelerName>Wockhardt USA LLC.</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13), 9 Plague (1.14).</IndicationAndUsage>
    <Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin is a white to light yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3&gt;Cu+2&gt;Zn+2&gt;Mg+2&gt;Ca+2. Excipients and Description of Dosage Forms. Levofloxacin Tablets. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: : 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide,  hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol,  polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide., 2 500 mg (as expressed in the anhydrous form):  colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol,  sodium starch glycolate and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, hypromellose,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide.</Description>
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