RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>63471-3010-0</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (63471-3010-0)  *  1 BOTTLE in 1 CARTON (63471-3006-2)  &gt; 59 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>63471-3010-00</NDC11Code>
    <ProductNDC>63471-3010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nix Family Pack Lice Killing Creme Rinse Kit</ProprietaryName>
    <NonProprietaryName>Permethrin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20131115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019918</ApplicationNumber>
    <LabelerName>Geodis Logistics LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats head lice.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63471-3000-0</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (63471-3000-0)  *  1 TUBE in 1 CARTON (63471-3001-2)  / 57 g in 1 TUBE *  1 TUBE in 1 CARTON (63471-3002-2)  / 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>63471-3000-00</NDC11Code>
    <ProductNDC>63471-3000</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Boudreauxs Rash Kicking</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20180525</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Geodis Logistics LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63471-3020-0</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (63471-3020-0)  *  1 BOTTLE in 1 CARTON (63471-3006-2)  &gt; 59 mL in 1 BOTTLE *  1 BOTTLE in 1 CARTON (63471-3008-5)  &gt; 147.86 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>63471-3020-00</NDC11Code>
    <ProductNDC>63471-3020</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nix Complete Lice Treatment</ProprietaryName>
    <NonProprietaryName>Permethrin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20131115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019918</ApplicationNumber>
    <LabelerName>Geodis Logistics LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50090-3010-0</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (50090-3010-0)  &gt; 28.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>50090-3010-00</NDC11Code>
    <ProductNDC>50090-3010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark</ProprietaryName>
    <ProprietaryNameSuffix>Double Antibiotic</ProprietaryNameSuffix>
    <NonProprietaryName>Bacitracin Zinc And Polymyxin B Sulfate</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19901205</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333B</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>BACITRACIN ZINC; POLYMYXIN B SULFATE</SubstanceName>
    <StrengthNumber>500; 10000</StrengthNumber>
    <StrengthUnit>[USP'U]/g; [USP'U]/g</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Synthesis &amp; Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61957-3010-0</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (61957-3010-0) </PackageDescription>
    <NDC11Code>61957-3010-00</NDC11Code>
    <ProductNDC>61957-3010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Forever Transfer-proof - 24h Foundation High Perfection Concentrated Floral Skincare With Sunscreen Broad Spectrum Spf 15 5w</ProprietaryName>
    <NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Parfums Christian Dior</LabelerName>
    <SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>35; 9.4</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70518-3010-0</NDCCode>
    <PackageDescription>30 POUCH in 1 BOX (70518-3010-0)  &gt; 1 TABLET, FILM COATED in 1 POUCH (70518-3010-1) </PackageDescription>
    <NDC11Code>70518-3010-00</NDC11Code>
    <ProductNDC>70518-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Latuda</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210202</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200603</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LATUDA is indicated for: : 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)] . , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression)  [see Clinical Studies (  14.2)] . .</IndicationAndUsage>
    <Description>LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2SHCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry ® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&amp;C Blue No. 2 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-3010-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-3010-1)</PackageDescription>
    <NDC11Code>36987-3010-01</NDC11Code>
    <ProductNDC>36987-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lombardy Poplar</ProprietaryName>
    <NonProprietaryName>Lombardy Poplar</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>POPULUS NIGRA POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-3010-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3010-2)</PackageDescription>
    <NDC11Code>36987-3010-02</NDC11Code>
    <ProductNDC>36987-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lombardy Poplar</ProprietaryName>
    <NonProprietaryName>Lombardy Poplar</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>POPULUS NIGRA POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-3010-3</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-3010-3)</PackageDescription>
    <NDC11Code>36987-3010-03</NDC11Code>
    <ProductNDC>36987-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lombardy Poplar</ProprietaryName>
    <NonProprietaryName>Lombardy Poplar</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>POPULUS NIGRA POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-3010-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-3010-4)</PackageDescription>
    <NDC11Code>36987-3010-04</NDC11Code>
    <ProductNDC>36987-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lombardy Poplar</ProprietaryName>
    <NonProprietaryName>Lombardy Poplar</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>POPULUS NIGRA POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>68071-3010-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (68071-3010-3) </PackageDescription>
    <NDC11Code>68071-3010-03</NDC11Code>
    <ProductNDC>68071-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078203</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam.  The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68071-3010-4</NDCCode>
    <PackageDescription>45 TABLET in 1 BOTTLE (68071-3010-4) </PackageDescription>
    <NDC11Code>68071-3010-04</NDC11Code>
    <ProductNDC>68071-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078203</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam.  The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68071-3010-6</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (68071-3010-6) </PackageDescription>
    <NDC11Code>68071-3010-06</NDC11Code>
    <ProductNDC>68071-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078203</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam.  The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68071-3010-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (68071-3010-9) </PackageDescription>
    <NDC11Code>68071-3010-09</NDC11Code>
    <ProductNDC>68071-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078203</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam.  The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68992-3010-1</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (68992-3010-1)  / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>68992-3010-01</NDC11Code>
    <ProductNDC>68992-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Envarsus</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206406</ApplicationNumber>
    <LabelerName>Veloxis Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: 1 The prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants (1.1), 2 The prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants (1.2).</IndicationAndUsage>
    <Description>Tacrolimus is the active ingredient in ENVARSUS XR. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclo-hexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. ENVARSUS XR is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>68992-3010-3</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (68992-3010-3)  / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>68992-3010-03</NDC11Code>
    <ProductNDC>68992-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Envarsus</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206406</ApplicationNumber>
    <LabelerName>Veloxis Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: 1 The prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants (1.1), 2 The prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants (1.2).</IndicationAndUsage>
    <Description>Tacrolimus is the active ingredient in ENVARSUS XR. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclo-hexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. ENVARSUS XR is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-1</NDCCode>
    <PackageDescription>35 TABLET in 1 BOTTLE (71335-3010-1) </PackageDescription>
    <NDC11Code>71335-3010-01</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-2</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (71335-3010-2) </PackageDescription>
    <NDC11Code>71335-3010-02</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-3</NDCCode>
    <PackageDescription>51 TABLET in 1 BOTTLE (71335-3010-3) </PackageDescription>
    <NDC11Code>71335-3010-03</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-4</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71335-3010-4) </PackageDescription>
    <NDC11Code>71335-3010-04</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-5</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (71335-3010-5) </PackageDescription>
    <NDC11Code>71335-3010-05</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-6</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (71335-3010-6) </PackageDescription>
    <NDC11Code>71335-3010-06</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-7</NDCCode>
    <PackageDescription>55 TABLET in 1 BOTTLE (71335-3010-7) </PackageDescription>
    <NDC11Code>71335-3010-07</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-3010-8</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (71335-3010-8) </PackageDescription>
    <NDC11Code>71335-3010-08</NDC11Code>
    <ProductNDC>71335-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217695</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C22H29FO5. The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is. FDA approved dissolution test method differs from the USP dissolution test methods.</Description>
  </NDC>
  <NDC>
    <NDCCode>63471-3001-2</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (63471-3001-2)  / 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>63471-3001-02</NDC11Code>
    <ProductNDC>63471-3001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Boudreauxs Butt Diaper Rash Max Strength</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Geodis Logistics LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>g/113g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63471-3002-2</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (63471-3002-2)  / 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>63471-3002-02</NDC11Code>
    <ProductNDC>63471-3002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Boudreauxs Butt Diaper Rash Original</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Geodis Logistics LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/113g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63471-3005-2</NDCCode>
    <PackageDescription>2 BOTTLE, DROPPER in 1 CARTON (63471-3005-2)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>63471-3005-02</NDC11Code>
    <ProductNDC>63471-3005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clear Eyes Redness Relief Eye Drops Sterile</ProprietaryName>
    <NonProprietaryName>Glycerin, Naphazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20110427</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>Geodis Logistics LLC</LabelerName>
    <SubstanceName>GLYCERIN; NAPHAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5; .12</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the relief of redness of the eye due to minor eye irritations. for the temporary relief of burning and irritations due to dryness of the eye. for use as a protectant against further irritation or to relieve dryness of the eye.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63471-3006-2</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (63471-3006-2)  &gt; 59 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>63471-3006-02</NDC11Code>
    <ProductNDC>63471-3006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nix Lice Killing Creme Rinse</ProprietaryName>
    <NonProprietaryName>Permethrin</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019918</ApplicationNumber>
    <LabelerName>Geodis Logistics LLC</LabelerName>
    <SubstanceName>PERMETHRIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Pyrethrins [CS], Pyrethroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats head lice.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0074-3010-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3010-90)</PackageDescription>
    <NDC11Code>00074-3010-90</NDC11Code>
    <ProductNDC>0074-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Advicor</ProprietaryName>
    <NonProprietaryName>Niacin And Lovastatin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20011217</StartMarketingDate>
    <EndMarketingDate>20180131</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021249</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>NIACIN; LOVASTATIN</SubstanceName>
    <StrengthNumber>1000; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0093-3010-01</NDCCode>
    <PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-3010-01) </PackageDescription>
    <NDC11Code>00093-3010-01</NDC11Code>
    <ProductNDC>0093-3010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clozapine</ProprietaryName>
    <NonProprietaryName>Clozapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120830</StartMarketingDate>
    <EndMarketingDate>20200331</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021590</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA Inc</LabelerName>
    <SubstanceName>CLOZAPINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120830</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>