RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>81324-175-32</NDCCode>
    <PackageDescription>945 mL in 1 BOTTLE, PLASTIC (81324-175-32) </PackageDescription>
    <NDC11Code>81324-0175-32</NDC11Code>
    <ProductNDC>81324-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Research Solutions Consumer Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>81324-075-32</NDCCode>
    <PackageDescription>945 mL in 1 BOTTLE, PLASTIC (81324-075-32) </PackageDescription>
    <NDC11Code>81324-0075-32</NDC11Code>
    <ProductNDC>81324-075</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Research Solutions Consumer Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>81324-175-01</NDCCode>
    <PackageDescription>3750 mL in 1 BOTTLE, PLASTIC (81324-175-01) </PackageDescription>
    <NDC11Code>81324-0175-01</NDC11Code>
    <ProductNDC>81324-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Research Solutions Consumer Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>81324-175-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PLASTIC (81324-175-16) </PackageDescription>
    <NDC11Code>81324-0175-16</NDC11Code>
    <ProductNDC>81324-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Research Solutions Consumer Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>35000-175-32</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (35000-175-32)  / 93 g in 1 TUBE</PackageDescription>
    <NDC11Code>35000-0175-32</NDC11Code>
    <ProductNDC>35000-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Colgate Total Sf Whitening Gel</ProprietaryName>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20181101</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Colgate-Palmolive Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20181101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of cavities. helps prevent gingivitis. helps interfere with harmful effects of plaque associated with gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42571-175-24</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (42571-175-24)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-175-32) </PackageDescription>
    <NDC11Code>42571-0175-24</NDC11Code>
    <ProductNDC>42571-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205945</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated: 1 To reduce the risk of:.</IndicationAndUsage>
    <Description>Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1Hpyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is insoluble to very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and soluble to freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablets are coated with opadry white YS-1-7040 which contains hypromellose, polyethylene glycol, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-175-32</NDCCode>
    <PackageDescription>7 TABLET in 1 BOTTLE (67877-175-32) </PackageDescription>
    <NDC11Code>67877-0175-32</NDC11Code>
    <ProductNDC>67877-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>71141-175-00</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (71141-175-00)  / 102 g in 1 TUBE (71141-175-32) </PackageDescription>
    <NDC11Code>71141-0175-00</NDC11Code>
    <ProductNDC>71141-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dentalux Coconut Minerals</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20210630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Lidl US LLC</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.239</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aids in the prevention of dental cavities. tube. box:.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71141-175-32</NDCCode>
    <PackageDescription>102 g in 1 TUBE (71141-175-32) </PackageDescription>
    <NDC11Code>71141-0175-32</NDC11Code>
    <ProductNDC>71141-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dentalux Coconut Minerals</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20210630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Lidl US LLC</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.239</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>74599-175-32</NDCCode>
    <PackageDescription>946 mL in 1 BOTTLE, PLASTIC (74599-175-32) </PackageDescription>
    <NDC11Code>74599-0175-32</NDC11Code>
    <ProductNDC>74599-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rush Sanitizers</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200421</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Netbrands Media Corp</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200421</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75816-175-32</NDCCode>
    <PackageDescription>946 mL in 1 BOTTLE, DISPENSING (75816-175-32) </PackageDescription>
    <NDC11Code>75816-0175-32</NDC11Code>
    <ProductNDC>75816-175</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Liquid Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200420</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Classic Coatings Systems</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0143-9666-06</NDCCode>
    <PackageDescription>6 CONTAINER in 1 CARTON (0143-9666-06)  / 200 mL in 1 CONTAINER (0143-9666-01) </PackageDescription>
    <NDC11Code>00143-9666-06</NDC11Code>
    <ProductNDC>0143-9666</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078764</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9667-06</NDCCode>
    <PackageDescription>6 CONTAINER in 1 CARTON (0143-9667-06)  / 100 mL in 1 CONTAINER (0143-9667-01) </PackageDescription>
    <NDC11Code>00143-9667-06</NDC11Code>
    <ProductNDC>0143-9667</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078764</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9668-06</NDCCode>
    <PackageDescription>6 CONTAINER in 1 CARTON (0143-9668-06)  / 200 mL in 1 CONTAINER (0143-9668-01) </PackageDescription>
    <NDC11Code>00143-9668-06</NDC11Code>
    <ProductNDC>0143-9668</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9668-10</NDCCode>
    <PackageDescription>10 CONTAINER in 1 CARTON (0143-9668-10)  / 200 mL in 1 CONTAINER (0143-9668-01) </PackageDescription>
    <NDC11Code>00143-9668-10</NDC11Code>
    <ProductNDC>0143-9668</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078698</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9669-06</NDCCode>
    <PackageDescription>6 CONTAINER in 1 CARTON (0143-9669-06)  / 100 mL in 1 CONTAINER (0143-9669-01) </PackageDescription>
    <NDC11Code>00143-9669-06</NDC11Code>
    <ProductNDC>0143-9669</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078698</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9669-10</NDCCode>
    <PackageDescription>10 CONTAINER in 1 CARTON (0143-9669-10)  / 100 mL in 1 CONTAINER (0143-9669-01) </PackageDescription>
    <NDC11Code>00143-9669-10</NDC11Code>
    <ProductNDC>0143-9669</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078698</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9899-91</NDCCode>
    <PackageDescription>6 VIAL in 1 CARTON (0143-9899-91)  / 100 mL in 1 VIAL (0143-9899-01) </PackageDescription>
    <NDC11Code>00143-9899-91</NDC11Code>
    <ProductNDC>0143-9899</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076736</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-4961-32</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0527-4961-32)  / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00527-4961-32</NDC11Code>
    <ProductNDC>0527-4961</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levothyroxine Sodium</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201102</StartMarketingDate>
    <EndMarketingDate>20250930</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021924</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>175</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20201102</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levothyroxine Sodium capsules are L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer (  1)  .</IndicationAndUsage>
    <Description>Levothyroxine Sodium capsules for oral use contain synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. Levothyroxine Sodium capsules are amber-colored, round/biconvex capsules containing a viscous amber-colored liquid. The inactive ingredients in Levothyroxine Sodium capsules are gelatin, glycerin and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>49502-806-93</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (49502-806-93)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32)  / 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>49502-0806-93</NDC11Code>
    <ProductNDC>49502-806</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Yupelri</ProprietaryName>
    <NonProprietaryName>Revefenacin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210598</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>REVEFENACIN</SubstanceName>
    <StrengthNumber>175</StrengthNumber>
    <StrengthUnit>ug/3mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</IndicationAndUsage>
    <Description>YUPELRI is a sterile, clear, colorless, aqueous solution of revefenacin. Revefenacin, the active component of YUPELRI, is an anticholinergic. The chemical name for revefenacin is 1-(2-{4-[(4-carbamoylpiperidin-1-yl)methyl]-N-methylbenzamido}ethyl)piperidin-4-yl N-({1,1’-biphenyl}-2-yl)carbamate; its structural formula is. Revefenacin has a molecular weight of 597.76 and its empirical formula is C35H43N5O4. Revefenacin is a white to off-white crystalline powder and is slightly soluble in water. YUPELRI is supplied as 3 mL of revefenacin solution packaged in a unit-dose low-density polyethylene vial overwrapped in a foil pouch. Each vial contains 175 mcg of revefenacin in 3 mL of an isotonic, sterile aqueous solution containing citric acid, sodium chloride, sodium citrate, and water for injection at pH 5.0. Hydrochloric acid or sodium hydroxide may be used to adjust the pH. YUPELRI does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the nebulization system used, and compressor performance. Using the PARI LC® Sprint nebulizer connected to a PARI Trek® S compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 62 mcg (35% of label claim), at a mean flow rate of 4 LPM. The mean nebulization time was 8 minutes. YUPELRI should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow, and equipped with a mouthpiece.</Description>
  </NDC>
  <NDC>
    <NDCCode>51285-138-50</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (51285-138-50)  *  100 TABLET, COATED in 1 BOTTLE (51285-175-02)  *  100 TABLET, COATED in 1 BOTTLE (51285-174-02) </PackageDescription>
    <NDC11Code>51285-0138-50</NDC11Code>
    <ProductNDC>51285-138</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Adenovirus Type 4 And Type 7 Vaccine, Live</ProprietaryName>
    <NonProprietaryName>Adenovirus Type 4 And Type 7 Vaccine, Live</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20110916</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125296</ApplicationNumber>
    <LabelerName>Teva Women's Health LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age.</IndicationAndUsage>
    <Description>Adenovirus Type 4 and Type 7 Vaccine, Live, Oral contains viable, selected strains of human adenovirus Type 4 and human adenovirus Type 7 prepared in human-diploid fibroblast cell cultures (strain WI-38).  The virus strains have not been attenuated.  The cells are grown and the virus growth maintained in Dulbecco’s Modified Eagle’s Medium, fetal bovine serum, and sodium bicarbonate.  The virus is harvested, freed of particulate cellular material by filtration, formulated and dried by lyophilization.  The dried virus material includes monosodium glutamate, sucrose, D-mannose, D-fructose, dextrose, human serum albumin, potassium phosphate, and plasdone C. The final vaccine is composed of two tablets (one tablet of Adenovirus Type 4 and one tablet of Adenovirus Type 7) designed to pass intact through the stomach and release the live virus in the intestine.  Each enteric-coated tablet contains an inner core tablet containing anhydrous lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate, and live adenovirus, either Type 4 or Type 7, at a potency of no fewer than 32,000 tissue-culture infective doses (4.5 log10 TCID50) per tablet.  The outer tablet layer contains microcrystalline cellulose, magnesium stearate, and anhydrous lactose, with an enteric coating consisting of cellulose acetate phthalate, alcohol, acetone, and castor oil.  The Type 7 tablet also contains FD&amp;C Yellow #6 aluminum lake dye.</Description>
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  <NDC>
    <NDCCode>64380-175-02</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (64380-175-02)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (64380-175-01) </PackageDescription>
    <NDC11Code>64380-0175-02</NDC11Code>
    <ProductNDC>64380-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
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    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078109</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1) . The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1).</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2.</Description>
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  <NDC>
    <NDCCode>67877-175-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (67877-175-01) </PackageDescription>
    <NDC11Code>67877-0175-01</NDC11Code>
    <ProductNDC>67877-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-175-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (67877-175-10) </PackageDescription>
    <NDC11Code>67877-0175-10</NDC11Code>
    <ProductNDC>67877-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-175-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (67877-175-30) </PackageDescription>
    <NDC11Code>67877-0175-30</NDC11Code>
    <ProductNDC>67877-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-175-35</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (67877-175-35)  / 10 TABLET in 1 BLISTER PACK (67877-175-33) </PackageDescription>
    <NDC11Code>67877-0175-35</NDC11Code>
    <ProductNDC>67877-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
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    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-175-85</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-175-85)  / 10 TABLET in 1 BLISTER PACK (67877-175-33) </PackageDescription>
    <NDC11Code>67877-0175-85</NDC11Code>
    <ProductNDC>67877-175</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202295</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1), 2 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1), 3 Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 4 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2), 5 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3-to 4-week trials and one maintenance trial. (14.2), 6 Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 7 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 8 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2), 9 Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine and Fluoxetine in Combination for the:, 10 Treatment of depressive episodes associated with bipolar I disorder. (1.5), 11 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax., 12 Treatment of treatment resistant depression. (1.6), 13 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water.       Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine, USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&amp;C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>78206-210-01</NDCCode>
    <PackageDescription>1 TRAY in 1 BOX, UNIT-DOSE (78206-210-01)  / 1 INTRAUTERINE DEVICE in 1 TRAY</PackageDescription>
    <NDC11Code>78206-0210-01</NDC11Code>
    <ProductNDC>78206-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Miudella</ProprietaryName>
    <NonProprietaryName>Copper</NonProprietaryName>
    <DosageFormName>INTRAUTERINE DEVICE</DosageFormName>
    <RouteName>INTRAUTERINE</RouteName>
    <StartMarketingDate>20251201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218201</ApplicationNumber>
    <LabelerName>Organon LLC</LabelerName>
    <SubstanceName>COPPER</SubstanceName>
    <StrengthNumber>175</StrengthNumber>
    <StrengthUnit>mm/1</StrengthUnit>
    <Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.</IndicationAndUsage>
    <Description>Miudella (copper intrauterine system) contains 99.99% pure copper for use as a contraceptive. Copper (Cu) has a molecular weight of 63.546 g/mol. Miudella consists of ten copper sleeves attached to a flexible nitinol (nickel-titanium alloy) frame measuring 32 mm horizontally and 30 mm vertically, and a polypropylene monofilament retrieval thread tied to the vertical stem. Miudella has a total exposed copper surface area of 175 mm2 and is provided sterile and preloaded in an inserter. Figure C: Diagram of Miudella.</Description>
  </NDC>
  <NDC>
    <NDCCode>82686-300-01</NDCCode>
    <PackageDescription>1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01)  / 1 INTRAUTERINE DEVICE in 1 TRAY</PackageDescription>
    <NDC11Code>82686-0300-01</NDC11Code>
    <ProductNDC>82686-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Miudella</ProprietaryName>
    <NonProprietaryName>Copper</NonProprietaryName>
    <DosageFormName>INTRAUTERINE DEVICE</DosageFormName>
    <RouteName>INTRAUTERINE</RouteName>
    <StartMarketingDate>20251201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218201</ApplicationNumber>
    <LabelerName>Sebela Women's Health Inc.</LabelerName>
    <SubstanceName>COPPER</SubstanceName>
    <StrengthNumber>175</StrengthNumber>
    <StrengthUnit>mm/1</StrengthUnit>
    <Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.</IndicationAndUsage>
    <Description>Miudella (copper intrauterine system) contains 99.99% pure copper for use as a contraceptive. Copper (Cu) has a molecular weight of 63.546 g/mol. Miudella consists of ten copper sleeves attached to a flexible nitinol (nickel-titanium alloy) frame measuring 32 mm horizontally and 30 mm vertically, and a polypropylene monofilament retrieval thread tied to the vertical stem. Miudella has a total exposed copper surface area of 175 mm2 and is provided sterile and preloaded in an inserter. Figure C: Diagram of Miudella.</Description>
  </NDC>
  <NDC>
    <NDCCode>81324-075-01</NDCCode>
    <PackageDescription>3750 mL in 1 BOTTLE, PLASTIC (81324-075-01) </PackageDescription>
    <NDC11Code>81324-0075-01</NDC11Code>
    <ProductNDC>81324-075</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Research Solutions Consumer Products, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>