RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>69482-700-66</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69482-700-66)  &gt; 100 g in 1 TUBE (69482-700-99) </PackageDescription>
    <NDC11Code>69482-0700-66</NDC11Code>
    <ProductNDC>69482-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Impoyz</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209483</ApplicationNumber>
    <LabelerName>Encore Dermatology, Inc</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55118-700-66</NDCCode>
    <PackageDescription>2 BOTTLE, DISPENSING in 1 CARTON (55118-700-66)  &gt; 1500 mL in 1 BOTTLE, DISPENSING (55118-700-15) </PackageDescription>
    <NDC11Code>55118-0700-66</NDC11Code>
    <ProductNDC>55118-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kleenex Antimicrobial Foam Skin Cleanser</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Kimberly-Clark</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1000mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For personal hand hygiene to help prevent the spread of certain bacteria.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69482-700-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69482-700-60)  &gt; 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>69482-0700-60</NDC11Code>
    <ProductNDC>69482-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Impoyz</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209483</ApplicationNumber>
    <LabelerName>Encore Dermatology, Inc</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69482-700-99</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69482-700-99)  &gt; 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>69482-0700-99</NDC11Code>
    <ProductNDC>69482-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Impoyz</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209483</ApplicationNumber>
    <LabelerName>Encore Dermatology, Inc</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>IMPOYZ Cream 0.025% is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older.</IndicationAndUsage>
    <Description>IMPOYZ (clobetasol propionate) Cream, 0.025% for topical use contains clobetasol propionate, a synthetic and fluorinated corticosteroid. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β-hydroxy-16β-methyl-3,20-dioxopregna-1,4-dien-17-yl propanoate, and it has the following structural formula. Clobetasol propionate has a molecular formula of C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder practically insoluble in water. Each gram of IMPOYZ  Cream contains 0.25 mg clobetasol propionate. It is an oil-in-water emulsion intended for topical application and contains the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, cyclomethicone, diethylene glycol monoethyl ether, glyceryl stearate and PEG 100 stearate, isopropyl myristate, methyl paraben, propyl paraben, purified water and white wax.</Description>
  </NDC>
  <NDC>
    <NDCCode>54092-700-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 BOX (54092-700-01)  / 3 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>54092-0700-01</NDC11Code>
    <ProductNDC>54092-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Elaprase</ProprietaryName>
    <NonProprietaryName>Idursulfase</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20060724</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125151</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <SubstanceName>IDURSULFASE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC], alpha-Glucosidases [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations (8.4)].</IndicationAndUsage>
    <Description>ELAPRASE is a formulation of idursulfase, a purified form of human iduronate-2-sulfatase, a lysosomal enzyme. Idursulfase is produced by recombinant DNA technology in a human cell line. Idursulfase is an enzyme that hydrolyzes the 2-sulfate esters of terminal iduronate sulfate residues from the glycosaminoglycans dermatan sulfate and heparan sulfate in the lysosomes of various cell types. Idursulfase is a 525-amino acid glycoprotein with a molecular weight of approximately 76 kilodaltons. The enzyme contains eight asparagine-linked glycosylation sites occupied by complex oligosaccharide structures. The enzyme activity of idursulfase is dependent on the post-translational modification of a specific cysteine to formylglycine. Idursulfase has a specific activity ranging from 46 to 74 units/mg of protein (one unit is defined as the amount of enzyme required to hydrolyze 1 micromole of heparin disaccharide substrate per hour under the specified assay conditions). ELAPRASE is administered as an intravenous infusion and supplied as a sterile, nonpyrogenic clear to slightly opalescent, colorless solution that must be diluted prior to administration in 0.9% Sodium Chloride Injection, USP. Each vial contains an extractable volume of 3 mL with an idursulfase concentration of 2 mg/mL at a pH of approximately 6. Each vial contains 6 mg idursulfase, sodium chloride (24 mg), sodium phosphate monobasic monohydrate (6.75 mg), sodium phosphate dibasic heptahydrate (2.97 mg), and polysorbate 20 (0.66 mg). ELAPRASE does not contain preservatives. Each vial is for single use only.</Description>
  </NDC>
  <NDC>
    <NDCCode>72603-700-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (72603-700-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (72603-700-01) </PackageDescription>
    <NDC11Code>72603-0700-10</NDC11Code>
    <ProductNDC>72603-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; RETROBULBAR</RouteName>
    <StartMarketingDate>20241001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217821</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see  Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see  Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].</IndicationAndUsage>
    <Description>Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride, USP is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white or almost white, crystalline powder or colorless crystals that is soluble in water, freely soluble in alcohol. It has the molecular formula C 18H 28N 2O.HCl.H 2O and it has the following structural formula:.    Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>72603-700-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (72603-700-25)  / 10 mL in 1 VIAL, SINGLE-DOSE (72603-700-01) </PackageDescription>
    <NDC11Code>72603-0700-25</NDC11Code>
    <ProductNDC>72603-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; RETROBULBAR</RouteName>
    <StartMarketingDate>20241001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217821</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see  Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see  Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].</IndicationAndUsage>
    <Description>Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride, USP is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white or almost white, crystalline powder or colorless crystals that is soluble in water, freely soluble in alcohol. It has the molecular formula C 18H 28N 2O.HCl.H 2O and it has the following structural formula:.    Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>78424-700-50</NDCCode>
    <PackageDescription>50 CLOTH in 1 PACKET (78424-700-50) </PackageDescription>
    <NDC11Code>78424-0700-50</NDC11Code>
    <ProductNDC>78424-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jnn-ii Clean-l Safe Hand Wipes</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200923</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>JOY LIFE Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>2.66</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ Store between 15-30 °C (59-86 °F). ■ Avoid freezing and excessive heat above 40 °C (104 °F).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69482-450-06</NDCCode>
    <PackageDescription>6 CAPSULE in 1 BOTTLE (69482-450-06) </PackageDescription>
    <NDC11Code>69482-0450-06</NDC11Code>
    <ProductNDC>69482-450</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Okebo</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204234</ApplicationNumber>
    <LabelerName>Encore Dermatology Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Okebo and other antibacterial drugs. Okebo 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. Doxycycline is indicated for the treatment of the following infections: 1   Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2   Respiratory tract infections caused by Mycoplasma pneumoniae., 3   Lymphogranuloma venereum caused by Chlamydia trachomatis., 4   Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5   Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence., 6   Inclusion conjunctivitis caused by Chlamydia trachomatis., 7   Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis., 8   Nongonococcal urethritis caused by Ureaplasma urealyticum., 9   Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
    <Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Okebo (Doxycycline monohydrate USP) Capsules, 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A Potato. Hard gelatin capsule contains black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69482-450-50</NDCCode>
    <PackageDescription>50 CAPSULE in 1 BOTTLE (69482-450-50) </PackageDescription>
    <NDC11Code>69482-0450-50</NDC11Code>
    <ProductNDC>69482-450</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Okebo</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204234</ApplicationNumber>
    <LabelerName>Encore Dermatology Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Okebo and other antibacterial drugs. Okebo 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. Doxycycline is indicated for the treatment of the following infections: 1   Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2   Respiratory tract infections caused by Mycoplasma pneumoniae., 3   Lymphogranuloma venereum caused by Chlamydia trachomatis., 4   Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5   Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence., 6   Inclusion conjunctivitis caused by Chlamydia trachomatis., 7   Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis., 8   Nongonococcal urethritis caused by Ureaplasma urealyticum., 9   Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
    <Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Okebo (Doxycycline monohydrate USP) Capsules, 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A Potato. Hard gelatin capsule contains black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69482-475-06</NDCCode>
    <PackageDescription>6 CAPSULE in 1 BOTTLE (69482-475-06) </PackageDescription>
    <NDC11Code>69482-0475-06</NDC11Code>
    <ProductNDC>69482-475</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Okebo</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204234</ApplicationNumber>
    <LabelerName>Encore Dermatology Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Okebo and other antibacterial drugs. Okebo 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. Doxycycline is indicated for the treatment of the following infections: 1   Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2   Respiratory tract infections caused by Mycoplasma pneumoniae., 3   Lymphogranuloma venereum caused by Chlamydia trachomatis., 4   Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5   Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence., 6   Inclusion conjunctivitis caused by Chlamydia trachomatis., 7   Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis., 8   Nongonococcal urethritis caused by Ureaplasma urealyticum., 9   Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
    <Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Okebo (Doxycycline monohydrate USP) Capsules, 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A Potato. Hard gelatin capsule contains black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69482-475-99</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (69482-475-99) </PackageDescription>
    <NDC11Code>69482-0475-99</NDC11Code>
    <ProductNDC>69482-475</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Okebo</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204234</ApplicationNumber>
    <LabelerName>Encore Dermatology Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Okebo and other antibacterial drugs. Okebo 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. Doxycycline is indicated for the treatment of the following infections: 1   Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2   Respiratory tract infections caused by Mycoplasma pneumoniae., 3   Lymphogranuloma venereum caused by Chlamydia trachomatis., 4   Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5   Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence., 6   Inclusion conjunctivitis caused by Chlamydia trachomatis., 7   Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis., 8   Nongonococcal urethritis caused by Ureaplasma urealyticum., 9   Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
    <Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Okebo (Doxycycline monohydrate USP) Capsules, 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A Potato. Hard gelatin capsule contains black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69482-600-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69482-600-60)  &gt; 1 g in 1 TUBE</PackageDescription>
    <NDC11Code>69482-0600-60</NDC11Code>
    <ProductNDC>69482-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tridesilon Cream</ProprietaryName>
    <NonProprietaryName>Desonide 0.05%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161001</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017010</ApplicationNumber>
    <LabelerName>Encore Dermatology Inc</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.03</StrengthNumber>
    <StrengthUnit>g/60g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2016-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69482-800-99</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (69482-800-99)  &gt; 120 g in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>69482-0800-99</NDC11Code>
    <ProductNDC>69482-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sernivo</ProprietaryName>
    <NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208079</ApplicationNumber>
    <LabelerName>Encore Dermatology Inc.</LabelerName>
    <SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.</IndicationAndUsage>
    <Description>SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-1220-48</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48)  / 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00002-1220-48</NDC11Code>
    <ProductNDC>0002-1220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tauvid</ProprietaryName>
    <NonProprietaryName>Flortaucipir F-18</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220701</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212123</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLORTAUCIPIR F-18</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).</IndicationAndUsage>
    <Description>TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-1220-50</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-50)  / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00002-1220-50</NDC11Code>
    <ProductNDC>0002-1220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tauvid</ProprietaryName>
    <NonProprietaryName>Flortaucipir F-18</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220701</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212123</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>FLORTAUCIPIR F-18</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).</IndicationAndUsage>
    <Description>TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0023-3348-07</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0023-3348-07)  / 1 IMPLANT in 1 POUCH</PackageDescription>
    <NDC11Code>00023-3348-07</NDC11Code>
    <ProductNDC>0023-3348</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ozurdex</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>IMPLANT</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022315</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OZURDEX is a corticosteroid indicated for: 1 The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) (1.1), 2 The treatment of non-infectious uveitis affecting the posterior segment of the eye (1.2), 3 The treatment of diabetic macular edema (1.3).</IndicationAndUsage>
    <Description>OZURDEX is a sterile intravitreal implant containing 0.7 mg (700 mcg) dexamethasone in the NOVADUR solid polymer sustained-release drug delivery system which does not contain an antimicrobial preservative. OZURDEX is preloaded into a single-use, DDS applicator to facilitate injection of the rodshaped implant directly into the vitreous. The NOVADUR system contains two poly D,L-lactide-co-glycolide (PLGA) polymer excipients. Both of these polymer materials have the same PLGA backbone, but the terminal end groups differ between them. One polymer, DL-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester, is ester terminated, and the other DL-Lactide and Glycolide (50:50) Copolymer 12000 Acid is acid terminated. The chemical name for dexamethasone is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β, 16α)-. Its structural formula is:. MW 392.47; molecular formula: C22H29FO5. Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol. The PLGA matrix slowly degrades to lactic acid and glycolic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0023-3348-08</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0023-3348-08)  / 1 IMPLANT in 1 POUCH</PackageDescription>
    <NDC11Code>00023-3348-08</NDC11Code>
    <ProductNDC>0023-3348</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ozurdex</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>IMPLANT</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022315</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>OZURDEX is a corticosteroid indicated for: 1 The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) (1.1), 2 The treatment of non-infectious uveitis affecting the posterior segment of the eye (1.2), 3 The treatment of diabetic macular edema (1.3).</IndicationAndUsage>
    <Description>OZURDEX is a sterile intravitreal implant containing 0.7 mg (700 mcg) dexamethasone in the NOVADUR solid polymer sustained-release drug delivery system which does not contain an antimicrobial preservative. OZURDEX is preloaded into a single-use, DDS applicator to facilitate injection of the rodshaped implant directly into the vitreous. The NOVADUR system contains two poly D,L-lactide-co-glycolide (PLGA) polymer excipients. Both of these polymer materials have the same PLGA backbone, but the terminal end groups differ between them. One polymer, DL-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester, is ester terminated, and the other DL-Lactide and Glycolide (50:50) Copolymer 12000 Acid is acid terminated. The chemical name for dexamethasone is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β, 16α)-. Its structural formula is:. MW 392.47; molecular formula: C22H29FO5. Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol. The PLGA matrix slowly degrades to lactic acid and glycolic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0449-49</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0054-0449-49)  / 105 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00054-0449-49</NDC11Code>
    <ProductNDC>0054-0449</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Posaconazole</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208773</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows: : 1 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in adults and pediatric patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. (1.2) , 2 Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients aged 13 years and older. (1.3).</IndicationAndUsage>
    <Description>Posaconazole is an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white to off-white powder that is practically insoluble in water. Posaconazole oral suspension is a white to off-white, cherry-brandy flavored immediate-release suspension containing 40 mg of posaconazole per mL and the following inactive ingredients: cherry-brandy flavor, citric acid monohydrate, hydroxyethyl cellulose, glycerin, polyoxyl 35 castor oil, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, titanium dioxide, and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>0085-1328-01</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0085-1328-01)  / 105 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00085-1328-01</NDC11Code>
    <ProductNDC>0085-1328</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Noxafil</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060915</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022003</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2  Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
    <Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
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  <NDC>
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    <PackageDescription>8 PACKET in 1 CARTON (0085-2224-02)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (0085-2224-01) </PackageDescription>
    <NDC11Code>00085-2224-02</NDC11Code>
    <ProductNDC>0085-2224</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Noxafil</ProprietaryName>
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    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214770</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2  Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
    <Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0085-4324-02</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (0085-4324-02) </PackageDescription>
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    <ProductNDC>0085-4324</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Noxafil</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
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    <StartMarketingDate>20131125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205053</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2  Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
    <Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
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  <NDC>
    <NDCCode>0085-4331-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (0085-4331-01)  / 16.7 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>00085-4331-01</NDC11Code>
    <ProductNDC>0085-4331</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Noxafil</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20140313</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205596</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>18</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2  Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
    <Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
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  <NDC>
    <NDCCode>0115-1309-38</NDCCode>
    <PackageDescription>700 TABLET, FILM COATED in 1 BOTTLE (0115-1309-38) </PackageDescription>
    <NDC11Code>00115-1309-38</NDC11Code>
    <ProductNDC>0115-1309</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sevelamer Carbonate</ProprietaryName>
    <NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
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    <StartMarketingDate>20171023</StartMarketingDate>
    <EndMarketingDate>20191231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090975</ApplicationNumber>
    <LabelerName>Impax Generics</LabelerName>
    <SubstanceName>SEVELAMER CARBONATE</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20171023</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0169-3105-11</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0169-3105-11)  / 1.5 mL in 1 SYRINGE (0169-3105-01) </PackageDescription>
    <NDC11Code>00169-3105-11</NDC11Code>
    <ProductNDC>0169-3105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Awiqli</ProprietaryName>
    <NonProprietaryName>Insulin Icodec-abae</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260803</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761326</ApplicationNumber>
    <LabelerName>Novo Nordisk Pharmaceutical Industries, LP</LabelerName>
    <SubstanceName>INSULIN ICODEC</SubstanceName>
    <StrengthNumber>700</StrengthNumber>
    <StrengthUnit>U/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260803</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0169-3121-13</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (0169-3121-13)  / 3 mL in 1 SYRINGE (0169-3121-01) </PackageDescription>
    <NDC11Code>00169-3121-13</NDC11Code>
    <ProductNDC>0169-3121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Awiqli</ProprietaryName>
    <NonProprietaryName>Insulin Icodec-abae</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260326</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761326</ApplicationNumber>
    <LabelerName>Novo Nordisk</LabelerName>
    <SubstanceName>INSULIN ICODEC</SubstanceName>
    <StrengthNumber>700</StrengthNumber>
    <StrengthUnit>U/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Insulin icodec-abae is a once-weekly basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin icodec-abae differs from human insulin in that the amino acid threonine in position B30 has been omitted, Tyr(A14) has been substituted with Glu and Tyr(B16) and Phe(B25) have been substituted with His. The side chain is connected to the peptide backbone via the amino group in the side chain at Lys(B29). Insulin icodec-abae has a molecular formula of C280H435N71O87S6 and a molecular weight of 6380.26 Da. It has the following structure. Figure 1: Structural Formula of Insulin icodec-abae. Awiqli (insulin icodec-abae) injection is a sterile, clear and colorless solution available as 700 units/mL (U-700) for subcutaneous use. Each mL contains 700 units of insulin icodec-abae and glycerin (15 mg), metacresol (1.08 mg), phenol (5.65 mg), sodium chloride (1.17 mg), zinc acetate (101 mcg), and Water for Injection. Awiqli has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH.</Description>
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    <NDC11Code>00169-3170-97</NDC11Code>
    <ProductNDC>0169-3170</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Awiqli</ProprietaryName>
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    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
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    <StartMarketingDate>20260811</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761326</ApplicationNumber>
    <LabelerName>Novo Nordisk Pharmaceutical Industries, LP</LabelerName>
    <SubstanceName>INSULIN ICODEC</SubstanceName>
    <StrengthNumber>700</StrengthNumber>
    <StrengthUnit>U/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260811</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
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  <NDC>
    <NDCCode>0254-1016-36</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0254-1016-36)  / 105 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00254-1016-36</NDC11Code>
    <ProductNDC>0254-1016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Posaconazole</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230329</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA022003</ApplicationNumber>
    <LabelerName>ENDO USA, Inc.</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 2 years of age and older who weigh greater than 40 kg. (1.1), 2 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgPosaconazole oral suspension: adults and pediatric patients 13 years of age and older, 3 Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older. (1.3).</IndicationAndUsage>
    <Description>Posaconazole delayed-release tablets and Posaconazole oral suspension contain posaconazole; an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Posaconazole Delayed-Release Tablets. Posaconazole delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Posaconazole Oral Suspension. Posaconazole oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0254-2045-02</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (0254-2045-02) </PackageDescription>
    <NDC11Code>00254-2045-02</NDC11Code>
    <ProductNDC>0254-2045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Posaconazole</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190830</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA205053</ApplicationNumber>
    <LabelerName>ENDO USA, Inc.</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 2 years of age and older who weigh greater than 40 kg. (1.1), 2 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgPosaconazole oral suspension: adults and pediatric patients 13 years of age and older, 3 Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older. (1.3).</IndicationAndUsage>
    <Description>Posaconazole delayed-release tablets and Posaconazole oral suspension contain posaconazole; an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Posaconazole Delayed-Release Tablets. Posaconazole delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Posaconazole Oral Suspension. Posaconazole oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0712-24</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (0338-0712-24)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-0712-24</NDC11Code>
    <ProductNDC>0338-0712</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Daptomycin In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213645</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daptomycin in Sodium Chloride Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved (1.1) and, , 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients for whom appropriate dosing can be achieved, including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved. (1.3).</IndicationAndUsage>
    <Description>Daptomycin in Sodium Chloride Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ℇ1-lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin in Sodium Chloride Injection is a single-dose frozen, premixed, iso-osmotic, sterile, nonpyrogenic solution containing either 350 milligrams or 500 milligrams of daptomycin, per 50 mL GALAXY container (PL 2040 Plastic); or 700 milligrams or 1,000 milligrams daptomycin, per 100 mL GALAXY container (PL 2040 Plastic). Daptomycin in Sodium Chloride Injection must be a clear, slightly yellow solution. Sodium Chloride, USP (0.9%) has been added to adjust osmolality. The approximate osmolality is 320 mOsmol/kg. Monobasic Sodium Phosphate, USP and Dibasic Sodium Phosphate, USP were added as buffer agents and the pH may have been adjusted with Hydrochloric Acid, NF and/or Sodium Hydroxide, NF. Water for Injection, USP is added as drug vehicle. Contains no preservative. The solution is intended for intravenous use after thawing to room temperature. This GALAXY container (PL 2040 Plastic) is fabricated from a specially designed multilayer plastic (PL 2040). 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. However, 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>
</NDCList>