RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>68001-480-35</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35)  / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0480-35</NDC11Code>
    <ProductNDC>68001-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Irinotecan Hydrochloide</ProprietaryName>
    <NonProprietaryName>Irinotecan Hydrochloide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212993</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.</IndicationAndUsage>
    <Description>Irinotecan hydrochloride injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan hydrochloride injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.  Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminataor is chemically synthesized. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate. Its empirical formula is C 33H 38N 4O 6HCl3H 2O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-480-22</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0480-22</NDC11Code>
    <ProductNDC>68001-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Irinotecan Hydrochloide</ProprietaryName>
    <NonProprietaryName>Irinotecan Hydrochloide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212993</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.</IndicationAndUsage>
    <Description>Irinotecan hydrochloride injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan hydrochloride injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.  Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminataor is chemically synthesized. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate. Its empirical formula is C 33H 38N 4O 6HCl3H 2O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-284-34</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (68001-284-34)  &gt; 2 mL in 1 VIAL (68001-284-35) </PackageDescription>
    <NDC11Code>68001-0284-34</NDC11Code>
    <ProductNDC>68001-284</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Irinotecan Hydrochloride</ProprietaryName>
    <NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20080220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077219</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68001-352-71</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (68001-352-71)  &gt; 2 mL in 1 VIAL (68001-352-35) </PackageDescription>
    <NDC11Code>68001-0352-71</NDC11Code>
    <ProductNDC>68001-352</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180430</StartMarketingDate>
    <EndMarketingDate>20220831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208973</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180430</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68001-425-35</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (68001-425-35)  &gt; 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>68001-0425-35</NDC11Code>
    <ProductNDC>68001-425</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Irinotecan Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>40 Mg/2 Ml</ProprietaryNameSuffix>
    <NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200707</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208718</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>18860-480-30</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (18860-480-30)  &gt; 35 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>18860-0480-30</NDC11Code>
    <ProductNDC>18860-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Elestrin</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20070601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021813</ApplicationNumber>
    <LabelerName>Jazz Pharmaceuticals Commercial Corp.</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-06</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>18860-480-60</NDCCode>
    <PackageDescription>2 BOTTLE, PUMP in 1 CARTON (18860-480-60)  &gt; 35 g in 1 BOTTLE, PUMP (18860-480-01)</PackageDescription>
    <NDC11Code>18860-0480-60</NDC11Code>
    <ProductNDC>18860-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Elestrin</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20070601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021813</ApplicationNumber>
    <LabelerName>Jazz Pharmaceuticals Commercial Corp.</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-06</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-480-35</NDCCode>
    <PackageDescription>100 g in 1 DRUM (43744-480-35)</PackageDescription>
    <NDC11Code>43744-0480-35</NDC11Code>
    <ProductNDC>43744-480</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110218</StartMarketingDate>
    <EndMarketingDate>20110219</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>HYDROXYZINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20110219</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>71610-480-35</NDCCode>
    <PackageDescription>35 TABLET in 1 BOTTLE (71610-480-35) </PackageDescription>
    <NDC11Code>71610-0480-35</NDC11Code>
    <ProductNDC>71610-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Warfarin Sodium</ProprietaryName>
    <NonProprietaryName>Warfarin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040616</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>WARFARIN SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
    <Description>Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows. C19H15NaO4 M.W. 330.31. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&amp;C red no. 40. The 2 mg also contains FD&amp;C blue no. 2 aluminum lake and FD&amp;C red no. 40 aluminum lake. The 2.5 mg also contains D&amp;C yellow no. 10 aluminum lake and FD&amp;C blue no. 1 aluminum lake. The 3 mg also contains FD&amp;C yellow no. 6 aluminum lake, FD&amp;C blue no. 2 aluminum lake, FD&amp;C red no. 40 aluminum lake, and D&amp;C yellow no. 10 aluminum lake. The 4 mg also contains FD&amp;C blue no. 1 aluminum lake and FD&amp;C blue no. 2 aluminum lake. The 5 mg also contains FD&amp;C yellow no. 6 aluminum lake, FD&amp;C red no. 40 aluminum lake and D&amp;C yellow no. 10 aluminum lake. The 6 mg also contains D&amp;C yellow no. 10 aluminum lake and FD&amp;C blue no. 1 aluminum lake. The 7.5 mg also contains FD&amp;C yellow no. 5 (tartrazine) aluminum lake and FD&amp;C red no. 40 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>76354-480-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (76354-480-01)  / 35.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>76354-0480-01</NDC11Code>
    <ProductNDC>76354-480</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Well People Bio Tint Spf 30 Sunscreen 3n</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>e.l.f. Cosmetics, Inc</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68001-406-73</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (68001-406-73)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>68001-0406-73</NDC11Code>
    <ProductNDC>68001-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204125</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP is a white, almost white, or tan lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, a clear solution is achieved with the pH of the solution is between 2.5 and 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9]oxadiazacyclohexadecino[4,5- m] [10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24∙HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package). AFTER RECONSTITUTION, FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-407-75</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (68001-407-75)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>68001-0407-75</NDC11Code>
    <ProductNDC>68001-407</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204125</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP is a white, almost white, or tan lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, a clear solution is achieved with the pH of the solution is between 2.5 and 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9]oxadiazacyclohexadecino[4,5- m] [10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24∙HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package). AFTER RECONSTITUTION, FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-465-62</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (68001-465-62)  &gt; 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68001-465-61) </PackageDescription>
    <NDC11Code>68001-0465-62</NDC11Code>
    <ProductNDC>68001-465</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204107</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomem-branous colitis produced by  C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3  R*,6  S*(  S*),7  S*,22  S*,23  R*,26  R*,36  S*,38a  S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22  H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1  H,16  H-[1,6,9]oxadiazacyclohexadecino[4,5-  m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, mono-hydrochloride. The molecular formula is C  66H  75Cl  2N  9O  24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-466-64</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (68001-466-64)  &gt; 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68001-466-63) </PackageDescription>
    <NDC11Code>68001-0466-64</NDC11Code>
    <ProductNDC>68001-466</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204107</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomem-branous colitis produced by  C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3  R*,6  S*(  S*),7  S*,22  S*,23  R*,26  R*,36  S*,38a  S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22  H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1  H,16  H-[1,6,9]oxadiazacyclohexadecino[4,5-  m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, mono-hydrochloride. The molecular formula is C  66H  75Cl  2N  9O  24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-487-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-487-06) </PackageDescription>
    <NDC11Code>68001-0487-06</NDC11Code>
    <ProductNDC>68001-487</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Capecitabine</ProprietaryName>
    <NonProprietaryName>Capecitabine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202593</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>CAPECITABINE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Capecitabine is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer. ● adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1). ● perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.( 1.1). ● treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1). Breast Cancer. ● treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. ( 1.2). ● treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. ( 1.2). Gastric, Esophageal, or Gastroesophageal Junction Cancer. ● treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. ( 1.3). ● treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. ( 1.3). Pancreatic Cancer. ● adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. ( 1.4).</IndicationAndUsage>
    <Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N- [(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C. Capecitabine tablets, USP are supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in capecitabine tablets include: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose and magnesium stearate. The peach or light peach film coating contains hypromellose, purified talc, titanium dioxide and ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-488-07</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-488-07) </PackageDescription>
    <NDC11Code>68001-0488-07</NDC11Code>
    <ProductNDC>68001-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Capecitabine</ProprietaryName>
    <NonProprietaryName>Capecitabine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202593</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>CAPECITABINE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Capecitabine is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer. ● adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1). ● perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.( 1.1). ● treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1). Breast Cancer. ● treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. ( 1.2). ● treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. ( 1.2). Gastric, Esophageal, or Gastroesophageal Junction Cancer. ● treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. ( 1.3). ● treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. ( 1.3). Pancreatic Cancer. ● adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. ( 1.4).</IndicationAndUsage>
    <Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N- [(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C. Capecitabine tablets, USP are supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in capecitabine tablets include: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose and magnesium stearate. The peach or light peach film coating contains hypromellose, purified talc, titanium dioxide and ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-506-30</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (68001-506-30)  / 10 mL in 1 VIAL, SINGLE-DOSE (68001-506-28) </PackageDescription>
    <NDC11Code>68001-0506-30</NDC11Code>
    <ProductNDC>68001-506</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204959</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>2; .25</StrengthNumber>
    <StrengthUnit>g/10mL; g/10mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piperacillin and Tazobactam for Injection, USP is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2) , 3 Skin and skin structure infections in adults ( 1.3) , 4 Female pelvic infections in adults ( 1.4) , 5 Community-acquired pneumonia in adults ( 1.5) .</IndicationAndUsage>
    <Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination products consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2- phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na +) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. : 1 Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium., 2 Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium., 3 Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-507-82</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (68001-507-82)  / 15 mL in 1 VIAL, SINGLE-DOSE (68001-507-53) </PackageDescription>
    <NDC11Code>68001-0507-82</NDC11Code>
    <ProductNDC>68001-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204959</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>3; .375</StrengthNumber>
    <StrengthUnit>g/15mL; g/15mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piperacillin and Tazobactam for Injection, USP is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2) , 3 Skin and skin structure infections in adults ( 1.3) , 4 Female pelvic infections in adults ( 1.4) , 5 Community-acquired pneumonia in adults ( 1.5) .</IndicationAndUsage>
    <Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination products consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2- phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na +) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. : 1 Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium., 2 Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium., 3 Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-508-31</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (68001-508-31)  / 20 mL in 1 VIAL, SINGLE-DOSE (68001-508-29) </PackageDescription>
    <NDC11Code>68001-0508-31</NDC11Code>
    <ProductNDC>68001-508</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204959</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>4; .5</StrengthNumber>
    <StrengthUnit>g/20mL; g/20mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Piperacillin and Tazobactam for Injection, USP is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2) , 3 Skin and skin structure infections in adults ( 1.3) , 4 Female pelvic infections in adults ( 1.4) , 5 Community-acquired pneumonia in adults ( 1.5) .</IndicationAndUsage>
    <Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination products consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S,5 R,6 R)-6-[( R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2- phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C 23H 26N 5NaO 7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S,3 S,5 R)-3-methyl-7-oxo-3-(1 H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10H 11N 4NaO 5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na +) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. : 1 Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium., 2 Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium., 3 Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-516-27</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (68001-516-27)  / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>68001-0516-27</NDC11Code>
    <ProductNDC>68001-516</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paclitaxel</ProprietaryName>
    <NonProprietaryName>Paclitaxel</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210914</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213434</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>PACLITAXEL</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES: Breast Carcinoma). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.</IndicationAndUsage>
    <Description>Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of purified polyoxyl 35 castor oil and 49.7% (v/v) dehydrated alcohol, USP and 2 mg citric acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via an extraction process from Taxus X media. The chemical name for paclitaxel is (2aR, 4S,4aS,6R, 9S ,11S ,12S ,12aR, 12bS )-1,2a,3,4, 4a,6,9,10, 11,12,12a,12b- Dodecahydro-4,6,9 ,11, 12, 12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]-benz[1,2-b]oxet-5-one6,12b-diacetate,12-benzoate,9-esterwith(2R,3S)-N-benzoyl-3-phenylisoserine Paclitaxel has the following structural formula:. Paclitaxel, USP is a white to off-white powder with the molecular formula C 47H 51NO 14 and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, soluble in alcohol, and melts at around 213 o to 222 oC.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-534-36</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (68001-534-36)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>68001-0534-36</NDC11Code>
    <ProductNDC>68001-534</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bortezomib</ProprietaryName>
    <NonProprietaryName>Bortezomib</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20220731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212958</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>BORTEZOMIB</SubstanceName>
    <StrengthNumber>3.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bortezomib for Injection is a proteasome inhibitor indicated for: 1 treatment of adult patients with multiple myeloma ( 1.1) , 2 treatment of adult patients with mantle cell lymphoma ( 1.2) .</IndicationAndUsage>
    <Description>Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure. The molecular weight is 384.24. The molecular formula is C 19H 25BN 4O 4.The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5. Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-540-36</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (68001-540-36)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>68001-0540-36</NDC11Code>
    <ProductNDC>68001-540</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bortezomib</ProprietaryName>
    <NonProprietaryName>Bortezomib</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20220516</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210824</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>BORTEZOMIB</SubstanceName>
    <StrengthNumber>3.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220516</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bortezomib for Injection is a proteasome inhibitor indicated for: 1 treatment of adult patients with multiple myeloma ( 1.1) , 2 treatment of adult patients with mantle cell lymphoma (  1.2)  .</IndicationAndUsage>
    <Description>Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure. The molecular weight is 384.24. The molecular formula is C 19H 25BN 4O 4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5. Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-541-36</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (68001-541-36)  / 3.5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>68001-0541-36</NDC11Code>
    <ProductNDC>68001-541</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bortezomib</ProprietaryName>
    <NonProprietaryName>Bortezomib</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20220731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209622</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>BORTEZOMIB</SubstanceName>
    <StrengthNumber>3.5</StrengthNumber>
    <StrengthUnit>mg/3.5mL</StrengthUnit>
    <Pharm_Classes>Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bortezomib for injection is a proteasome inhibitor indicated for: 1 treatment of adult patients with multiple myeloma ( 1.1) , 2 treatment of adult patients with mantle cell lymphoma ( 1.2) .</IndicationAndUsage>
    <Description>Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure:. The molecular weight is 384.24. The molecular formula is C 19H 25BN 4O 4. The solubility of bortezomib, is freely soluble in N, N dimethyl fornamide, soluble in methanol and practically insoluble in n-Hexane. Bortezomib is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-643-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68001-643-06) </PackageDescription>
    <NDC11Code>68001-0643-06</NDC11Code>
    <ProductNDC>68001-643</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Capecitabine</ProprietaryName>
    <NonProprietaryName>Capecitabine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250418</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210203</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>CAPECITABINE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250418</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine USP is a white or almost white powder. Capecitabine USP is freely soluble in anhydrous ethanol, sparingly soluble in water and practically insoluble in heptane. Capecitabine tablets, USP are supplied as oval shaped film-coated tablets for oral use. Each light peach colored tablet contains 150 mg capecitabine, USP and each light peach colored tablet contains 500 mg capecitabine, USP. The inactive ingredients in capecitabine tablets include: croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The peach or light peach film coating contains hypromellose, iron oxide red, iron oxide yellow, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-644-07</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68001-644-07) </PackageDescription>
    <NDC11Code>68001-0644-07</NDC11Code>
    <ProductNDC>68001-644</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Capecitabine</ProprietaryName>
    <NonProprietaryName>Capecitabine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210203</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>CAPECITABINE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine USP is a white or almost white powder. Capecitabine USP is freely soluble in anhydrous ethanol, sparingly soluble in water and practically insoluble in heptane. Capecitabine tablets, USP are supplied as oval shaped film-coated tablets for oral use. Each light peach colored tablet contains 150 mg capecitabine, USP and each light peach colored tablet contains 500 mg capecitabine, USP. The inactive ingredients in capecitabine tablets include: croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The peach or light peach film coating contains hypromellose, iron oxide red, iron oxide yellow, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-705-27</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (68001-705-27)  / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>68001-0705-27</NDC11Code>
    <ProductNDC>68001-705</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paclitaxel</ProprietaryName>
    <NonProprietaryName>Paclitaxel</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216874</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>PACLITAXEL</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.</IndicationAndUsage>
    <Description>Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, NF and 49.7% (v/v) dehydrated alcohol, USP and 2 mg citric acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β, 10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel, USP is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216° to 217°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-480-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (16590-480-30)</PackageDescription>
    <NDC11Code>16590-0480-30</NDC11Code>
    <ProductNDC>16590-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
    <NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078216</ApplicationNumber>
    <LabelerName>Stat Rx USA</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-480-45</NDCCode>
    <PackageDescription>45 TABLET in 1 BOTTLE (16590-480-45)</PackageDescription>
    <NDC11Code>16590-0480-45</NDC11Code>
    <ProductNDC>16590-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
    <NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078216</ApplicationNumber>
    <LabelerName>Stat Rx USA</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-480-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (16590-480-60)</PackageDescription>
    <NDC11Code>16590-0480-60</NDC11Code>
    <ProductNDC>16590-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
    <NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078216</ApplicationNumber>
    <LabelerName>Stat Rx USA</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-480-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (16590-480-90)</PackageDescription>
    <NDC11Code>16590-0480-90</NDC11Code>
    <ProductNDC>16590-480</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
    <NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078216</ApplicationNumber>
    <LabelerName>Stat Rx USA</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.</Description>
  </NDC>
</NDCList>