RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>59651-454-31</NDCCode>
    <PackageDescription>30000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (59651-454-31) </PackageDescription>
    <NDC11Code>59651-0454-31</NDC11Code>
    <ProductNDC>59651-454</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <StartMarketingDate>20250417</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180; 240</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>17-APR-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>59651-454-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (59651-454-99) </PackageDescription>
    <NDC11Code>59651-0454-99</NDC11Code>
    <ProductNDC>59651-454</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <StartMarketingDate>20250417</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180; 240</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>17-APR-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>59651-854-31</NDCCode>
    <PackageDescription>2500 TABLET, FILM COATED in 1 BAG (59651-854-31) </PackageDescription>
    <NDC11Code>59651-0854-31</NDC11Code>
    <ProductNDC>59651-854</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20240329</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-01-31</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-MAR-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-454-31</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (31722-454-31)  / 10 mL in 1 VIAL (31722-454-10) </PackageDescription>
    <NDC11Code>31722-0454-31</NDC11Code>
    <ProductNDC>31722-454</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zinc Sulfate</ProprietaryName>
    <NonProprietaryName>Zinc Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219585</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ZINC SULFATE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
    <Description>Zinc Sulfate Injection, USP is a sterile, non-pyrogenic, clear, colorless, and odorless solution intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial: Each mL contains 1 mg of zinc present as 2.46 mg of zinc sulfate and water for injection q.s. 30 mg/10 mL Pharmacy Bulk Package vial: Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection q.s. 25 mg/5 mL Pharmacy Bulk Package vial: Each mL contains 5 mg of zinc present as 12.32 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of zinc sulfate injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of zinc sulfate injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of zinc sulfate injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate USP has a molecular weight of 287.54 g/mol and a formula of ZnSO 4·7H 2O.</Description>
  </NDC>
  <NDC>
    <NDCCode>61554-311-31</NDCCode>
    <PackageDescription>454 g in 1 JAR (61554-311-31) </PackageDescription>
    <NDC11Code>61554-0311-31</NDC11Code>
    <ProductNDC>61554-311</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Claravie</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260821</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Gentell LLC</LabelerName>
    <SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260821</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
    <Description>Powered by nature, perfected by science—the ClaraVie skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-1019-48</NDCCode>
    <PackageDescription>100 mL in 1 BAG (0338-1019-48) </PackageDescription>
    <NDC11Code>00338-1019-48</NDC11Code>
    <ProductNDC>0338-1019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nafcillin</ProprietaryName>
    <NonProprietaryName>Nafcillin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19891031</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050655</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>NAFCILLIN SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19891031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus species, therapy with Nafcillin Injection, USP should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin Injection, USP and other antibacterial drugs, Nafcillin 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.</IndicationAndUsage>
    <Description>Nafcillin Injection, USP is a sterile injectable product containing nafcillin which is added as Nafcillin Sodium, USP, a semisynthetic penicillin derived from the penicillin nucleus, 6-aminopenicillanic acid. The chemical name of nafcillin sodium is Monosodium (2S,5R,6R)-6-(2-ethoxy-1-naphthamido)-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The molecular formula of Nafcillin Sodium, USP is C21H21N2NaO5S·H2O. The molecular weight is 454.48. The structural formula of nafcillin sodium is as follows. Nafcillin Injection, USP is a frozen, iso-osmotic, sterile, nonpyrogenic premixed 100 mL solution containing 2 g of nafcillin, added as Nafcillin Sodium, USP. Dextrose, USP has been added to the above dosages to adjust osmolality (approximately 3.6 g as dextrose hydrous to the 2 g dosage. Sodium Citrate Hydrous, USP has been added as a buffer (approximately 180 mg to the 2 g dosage. The pH has been adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. The pH is 6.5 (6.0 to 8.5). The solution is intended for intravenous use after thawing to room temperature. This Galaxy container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>0395-0200-01</NDCCode>
    <PackageDescription>454 g in 1 BOTTLE, PLASTIC (0395-0200-01) </PackageDescription>
    <NDC11Code>00395-0200-01</NDC11Code>
    <ProductNDC>0395-0200</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Barium Sulfate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <StartMarketingDate>19980325</StartMarketingDate>
    <EndMarketingDate>20230531</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Humco Holding Group, Inc.</LabelerName>
    <SubstanceName>BARIUM SULFATE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>11-MAR-14</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-MAY-23</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0574-2004-16</NDCCode>
    <PackageDescription>454 g in 1 BOTTLE, PLASTIC (0574-2004-16)</PackageDescription>
    <NDC11Code>00574-2004-16</NDC11Code>
    <ProductNDC>0574-2004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kionex</ProprietaryName>
    <NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL; RECTAL</RouteName>
    <StartMarketingDate>19980201</StartMarketingDate>
    <EndMarketingDate>20180731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040029</ApplicationNumber>
    <LabelerName>Paddock Laboratories, LLC</LabelerName>
    <SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
    <StrengthNumber>4.1</StrengthNumber>
    <StrengthUnit>meq/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-31</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>11770-1245-1</NDCCode>
    <PackageDescription>454 kg in 1 BOTTLE (11770-1245-1) </PackageDescription>
    <NDC11Code>11770-1245-01</NDC11Code>
    <ProductNDC>11770-1245</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20210331</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>DDP Specialty Electronic Materials US 9, LLC</LabelerName>
    <SubstanceName>DIMETHICONE; SILICON DIOXIDE</SubstanceName>
    <StrengthNumber>29.7; 1.3</StrengthNumber>
    <StrengthUnit>kg/100kg; kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAR-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>21130-454-34</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-454-34)  / 237 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0454-34</NDC11Code>
    <ProductNDC>21130-454</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tussin</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260715</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>20; 200</StrengthNumber>
    <StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>40085-028-16</NDCCode>
    <PackageDescription>454 g in 1 JAR (40085-028-16) </PackageDescription>
    <NDC11Code>40085-0028-16</NDC11Code>
    <ProductNDC>40085-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161001</StartMarketingDate>
    <EndMarketingDate>20180731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA011601</ApplicationNumber>
    <LabelerName>Renaissance Pharma, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161001</StartMarketingDatePackage>
    <EndMarketingDatePackage>20180731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>44567-221-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (44567-221-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0221-10</NDC11Code>
    <ProductNDC>44567-221</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nafcillin</ProprietaryName>
    <NonProprietaryName>Nafcillin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090560</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>NAFCILLIN SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection 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.</IndicationAndUsage>
    <Description>Nafcillin for Injection, USP is a sterile semisynthetic penicillin derived from 6-amino-penicillanic acid. It is the sodium salt in a parenteral dosage form. The chemical name of nafcillin sodium is Monosodium (2S, 5R, 6R)-6-(2-ethoxy-1-naphthamido)-3, 3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The structural formula of nafcillin sodium is as follows. C21H21N2NaO5S ●H2O                                       MW=454.47Nafcillin for Injection, USP for intramuscular or intravenous route of administration, contains nafcillin sodium as a sterile white to off-white crystalline dry powder for reconstitution. The reconstituted solution is a clear and colorless solution. The pH of the reconstituted solution is 6 to 8.5. Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial, is buffered with approximately 38 mg sodium citrate per gram. The sodium content is about 66 mg [2.9 mEq] per gram.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-222-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (44567-222-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0222-10</NDC11Code>
    <ProductNDC>44567-222</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nafcillin</ProprietaryName>
    <NonProprietaryName>Nafcillin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090560</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>NAFCILLIN SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection 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.</IndicationAndUsage>
    <Description>Nafcillin for Injection, USP is a sterile semisynthetic penicillin derived from 6-amino-penicillanic acid. It is the sodium salt in a parenteral dosage form. The chemical name of nafcillin sodium is Monosodium (2S, 5R, 6R)-6-(2-ethoxy-1-naphthamido)-3, 3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The structural formula of nafcillin sodium is as follows. C21H21N2NaO5S ●H2O                                       MW=454.47Nafcillin for Injection, USP for intramuscular or intravenous route of administration, contains nafcillin sodium as a sterile white to off-white crystalline dry powder for reconstitution. The reconstituted solution is a clear and colorless solution. The pH of the reconstituted solution is 6 to 8.5. Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial, is buffered with approximately 38 mg sodium citrate per gram. The sodium content is about 66 mg [2.9 mEq] per gram.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-730-31</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (46708-730-31) </PackageDescription>
    <NDC11Code>46708-0730-31</NDC11Code>
    <ProductNDC>46708-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methotrexate</ProprietaryName>
    <NonProprietaryName>Methotrexate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217552</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>METHOTREXATE SODIUM</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methotrexate tablets are a diydrofolate reductase inhibitor indicated for the:  Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1)  Treatment of adults with mycosis fungoides (1.1)  Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1)  Treatment of adults with rheumatoid arthritis (1.2)  Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3)  Treatment of adults with severe psoriasis (1.4).</IndicationAndUsage>
    <Description>Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C20H22N8O5 and the molecular weight is 454.4 g/mol. The structural formula is. Methotrexate tablets, USP for oral use is available in bottles of 36 and 100 tablets. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>51862-182-16</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (51862-182-16)  &gt; 454 g in 1 BOTTLE</PackageDescription>
    <NDC11Code>51862-0182-16</NDC11Code>
    <ProductNDC>51862-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Urea</ProprietaryName>
    <NonProprietaryName>Urea</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111007</StartMarketingDate>
    <EndMarketingDate>20180731</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mayne Pharma Inc.</LabelerName>
    <SubstanceName>UREA</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-31</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>62332-730-31</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (62332-730-31) </PackageDescription>
    <NDC11Code>62332-0730-31</NDC11Code>
    <ProductNDC>62332-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methotrexate</ProprietaryName>
    <NonProprietaryName>Methotrexate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217552</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>METHOTREXATE SODIUM</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methotrexate tablets are a diydrofolate reductase inhibitor indicated for the:  Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1)  Treatment of adults with mycosis fungoides (1.1)  Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1)  Treatment of adults with rheumatoid arthritis (1.2)  Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3)  Treatment of adults with severe psoriasis (1.4).</IndicationAndUsage>
    <Description>Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C20H22N8O5 and the molecular weight is 454.4 g/mol. The structural formula is. Methotrexate tablets, USP for oral use is available in bottles of 36 and 100 tablets. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-454-05</NDCCode>
    <PackageDescription>500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-05) </PackageDescription>
    <NDC11Code>67877-0454-05</NDC11Code>
    <ProductNDC>67877-454</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Itraconazole</ProprietaryName>
    <NonProprietaryName>Itraconazole</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208591</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>ITRACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients. 1. Blastomycosis, pulmonary and extrapulmonary. 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal. histoplasmosis, and. 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are. refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised. patients. 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and. 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.). Description of Clinical Studies. Blastomycosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. Histoplasmosis. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV-infected patients.  Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis. Analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of  effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail. Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail. Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.</IndicationAndUsage>
    <Description>Itraconazole, an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one. or. (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]- Δ2 -1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white or almost white powder. Freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol and practically insoluble in water. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres (composed of sucrose, maize starch and purified water). Inactive ingredients are hard gelatin capsule, hypromellose, poloxamer 188, ethanol absolute, methylene chloride, polyethylene glycol 20000, talc, colloidal silicon dioxide, SLS, titanium dioxide, FD&amp;C blue 1, FD&amp;C red 40, FD&amp;C red 3 and white ink (containing: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide and potassium hydroxide). FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-454-30</NDCCode>
    <PackageDescription>30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-30) </PackageDescription>
    <NDC11Code>67877-0454-30</NDC11Code>
    <ProductNDC>67877-454</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Itraconazole</ProprietaryName>
    <NonProprietaryName>Itraconazole</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208591</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>ITRACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients. 1. Blastomycosis, pulmonary and extrapulmonary. 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal. histoplasmosis, and. 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are. refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised. patients. 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and. 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.). Description of Clinical Studies. Blastomycosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. Histoplasmosis. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV-infected patients.  Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis. Analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of  effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail. Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail. Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.</IndicationAndUsage>
    <Description>Itraconazole, an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one. or. (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]- Δ2 -1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white or almost white powder. Freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol and practically insoluble in water. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres (composed of sucrose, maize starch and purified water). Inactive ingredients are hard gelatin capsule, hypromellose, poloxamer 188, ethanol absolute, methylene chloride, polyethylene glycol 20000, talc, colloidal silicon dioxide, SLS, titanium dioxide, FD&amp;C blue 1, FD&amp;C red 40, FD&amp;C red 3 and white ink (containing: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide and potassium hydroxide). FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-454-84</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (67877-454-84)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (67877-454-33) </PackageDescription>
    <NDC11Code>67877-0454-84</NDC11Code>
    <ProductNDC>67877-454</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Itraconazole</ProprietaryName>
    <NonProprietaryName>Itraconazole</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208591</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>ITRACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients. 1. Blastomycosis, pulmonary and extrapulmonary. 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal. histoplasmosis, and. 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are. refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised. patients. 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and. 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.). Description of Clinical Studies. Blastomycosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. Histoplasmosis. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV-infected patients.  Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis. Analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of  effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail. Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail. Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.</IndicationAndUsage>
    <Description>Itraconazole, an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one. or. (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]- Δ2 -1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white or almost white powder. Freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol and practically insoluble in water. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres (composed of sucrose, maize starch and purified water). Inactive ingredients are hard gelatin capsule, hypromellose, poloxamer 188, ethanol absolute, methylene chloride, polyethylene glycol 20000, talc, colloidal silicon dioxide, SLS, titanium dioxide, FD&amp;C blue 1, FD&amp;C red 40, FD&amp;C red 3 and white ink (containing: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide and potassium hydroxide). FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients. 1. Blastomycosis, pulmonary and extrapulmonary. 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal. histoplasmosis, and. 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are. refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised. patients. 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and. 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.). Description of Clinical Studies. Blastomycosis:. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. Histoplasmosis. Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV-infected patients.  Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis. Analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of  effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail. Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail. Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.</IndicationAndUsage>
    <Description>Itraconazole, an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2 -1,2,4-triazolin-5-one. or. (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]- Δ2 -1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white or almost white powder. Freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol and practically insoluble in water. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres (composed of sucrose, maize starch and purified water). Inactive ingredients are hard gelatin capsule, hypromellose, poloxamer 188, ethanol absolute, methylene chloride, polyethylene glycol 20000, talc, colloidal silicon dioxide, SLS, titanium dioxide, FD&amp;C blue 1, FD&amp;C red 40, FD&amp;C red 3 and white ink (containing: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide and potassium hydroxide). FDA approved dissolution test specifications differ from USP.</Description>
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    <NDCCode>70857-004-16</NDCCode>
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    <SubstanceName>ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; MATRICARIA RECUTITA; COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ATROPA BELLADONNA; MERCURIUS SOLUBILIS; CALCIUM SULFIDE</SubstanceName>
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    <IndicationAndUsage>When using this product: 1 do not get into eyes.</IndicationAndUsage>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Recovery Cream</ProprietaryName>
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    <LabelerName>Shenzhen Xiaomai Manufacturing Co., Ltd.</LabelerName>
    <SubstanceName>RETINOL</SubstanceName>
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    <IndicationAndUsage>Lighten skin spots, even skin tone, and make skin brighter.</IndicationAndUsage>
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    <LabelerName>Aurobindo Pharma Limited</LabelerName>
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    <Description>Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate.</Description>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.</IndicationAndUsage>
    <Description>Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate.</Description>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <LabelerName>Aurobindo Pharma Limited</LabelerName>
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    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.</IndicationAndUsage>
    <Description>Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-117-82</NDCCode>
    <PackageDescription>800 CAPSULE, LIQUID FILLED in 1 BAG (59651-117-82) </PackageDescription>
    <NDC11Code>59651-0117-82</NDC11Code>
    <ProductNDC>59651-117</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Diphenhydramine Hcl And Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <StartMarketingDate>20190214</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN</SubstanceName>
    <StrengthNumber>25; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-03-31</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>14-FEB-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>59651-180-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59651-180-30) </PackageDescription>
    <NDC11Code>59651-0180-30</NDC11Code>
    <ProductNDC>59651-180</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Letrozole</ProprietaryName>
    <NonProprietaryName>Letrozole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211717</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>LETROZOLE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. Letrozole is an aromatase inhibitor indicated for: 1  Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. (1.3).</IndicationAndUsage>
    <Description>Letrozole tablets USP for oral administration contains 2.5 mg of letrozole USP, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula isLetrozole USP is a white to yellowish crystalline powder, freely soluble in dichloromethane, slightly soluble in ethanol and insoluble in water. It has a molecular weight of 285.31 g/mol, molecular formula C17H11N5, and a melting range of 184°C to 185°C. Letrozole tablets USP is available as 2.5 mg tablets for oral administration.Inactive Ingredients: colloidal silicon dioxide, corn starch, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-180-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (59651-180-90) </PackageDescription>
    <NDC11Code>59651-0180-90</NDC11Code>
    <ProductNDC>59651-180</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Letrozole</ProprietaryName>
    <NonProprietaryName>Letrozole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211717</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>LETROZOLE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. Letrozole is an aromatase inhibitor indicated for: 1  Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. (1.3).</IndicationAndUsage>
    <Description>Letrozole tablets USP for oral administration contains 2.5 mg of letrozole USP, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula isLetrozole USP is a white to yellowish crystalline powder, freely soluble in dichloromethane, slightly soluble in ethanol and insoluble in water. It has a molecular weight of 285.31 g/mol, molecular formula C17H11N5, and a melting range of 184°C to 185°C. Letrozole tablets USP is available as 2.5 mg tablets for oral administration.Inactive Ingredients: colloidal silicon dioxide, corn starch, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-183-25</NDCCode>
    <PackageDescription>5 POUCH in 1 CARTON (59651-183-25)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
    <NDC11Code>59651-0183-25</NDC11Code>
    <ProductNDC>59651-183</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20200420</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211888</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>.63</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).</IndicationAndUsage>
    <Description>Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-­xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2  H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).</Description>
  </NDC>
</NDCList>