RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>64380-801-36</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (64380-801-36)  / 80 g in 1 TUBE</PackageDescription>
    <NDC11Code>64380-0801-36</NDC11Code>
    <ProductNDC>64380-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210346</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone Acetonide Cream 0.025%, 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-800-36</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (64380-800-36)  / 80 g in 1 TUBE</PackageDescription>
    <NDC11Code>64380-0800-36</NDC11Code>
    <ProductNDC>64380-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210346</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone Acetonide Cream 0.025%, 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-870-36</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (64380-870-36)  &gt; 80 g in 1 TUBE</PackageDescription>
    <NDC11Code>64380-0870-36</NDC11Code>
    <ProductNDC>64380-870</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211315</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone Acetonide Ointment 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with acetone. Graphic Formula. C24H31FO6, M.W. 434.50. Each gram of 0.1 %, and 0.5% Triamcinolone Acetonide Ointment, provides 1 mg, or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-801-22</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (64380-801-22)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>64380-0801-22</NDC11Code>
    <ProductNDC>64380-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210346</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone Acetonide Cream 0.025%, 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-801-23</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (64380-801-23)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>64380-0801-23</NDC11Code>
    <ProductNDC>64380-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210346</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone Acetonide Cream 0.025%, 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-801-37</NDCCode>
    <PackageDescription>454 g in 1 JAR (64380-801-37) </PackageDescription>
    <NDC11Code>64380-0801-37</NDC11Code>
    <ProductNDC>64380-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210346</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone Acetonide Cream 0.025%, 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
  </NDC>
  <NDC>
    <NDCCode>11084-801-36</NDCCode>
    <PackageDescription>255 g in 1 CAN (11084-801-36) </PackageDescription>
    <NDC11Code>11084-0801-36</NDC11Code>
    <ProductNDC>11084-801</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcare Foamed Antiseptic Handrub</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180201</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58602-801-36</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (58602-801-36)  &gt; 250 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>58602-0801-36</NDC11Code>
    <ProductNDC>58602-801</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208865</ApplicationNumber>
    <LabelerName>Aurohealth LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: headachemuscular aches minor pain of arthritistoothachebackachethe common cold menstrual crampstemporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68180-801-36</NDCCode>
    <PackageDescription>150 TABLET in 1 BOTTLE (68180-801-36) </PackageDescription>
    <NDC11Code>68180-0801-36</NDC11Code>
    <ProductNDC>68180-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lapatinib</ProprietaryName>
    <NonProprietaryName>Lapatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200929</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203007</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LAPATINIB DITOSYLATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lapatinib tablets are kinase inhibitor indicated in combination with: (1) : 1 capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. .</IndicationAndUsage>
    <Description>Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the ditosylate salt, with chemical name N-(3 chloro-4-[(3-fluorophenyl)methyl]oxy}phenyl)-6-[5-({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furanyl]-4-quinazolinamine bis(4-methylbenzenesulfonate). It has the molecular formula C29H26ClFN4O4S (C7H8O3S)2 and a molecular weight of 925.48 g/mol. Lapatinib ditosylate has the following chemical structure:. Lapatinib is a yellow solid, and its solubility in water is 0.007 mg/mL and in 0.1N HCl is 0.001 mg/mL at 25°C. Each 250 mg lapatinib film coated tablet contains 398 mg lapatinib ditosylate equivalent to 250 mg lapatinib free base. The inactive ingredients of lapatinib tablets are: FD &amp; C Yellow # 6/Sunset yellow FCF Aluminum lake, hypromellose, lecithin (soy), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, sodium starch glycolate, talc, titanium dioxide, xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>75111-801-36</NDCCode>
    <PackageDescription>900 CLOTH in 1 CANISTER (75111-801-36) </PackageDescription>
    <NDC11Code>75111-0801-36</NDC11Code>
    <ProductNDC>75111-801</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ipa Cleaning Wipe</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Enping Jiaxin Daily Necessities Co., Ltd.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>1/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>IPA Cleaning Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85789-801-36</NDCCode>
    <PackageDescription>36 TABLET, FILM COATED in 1 BOTTLE (85789-801-36) </PackageDescription>
    <NDC11Code>85789-0801-36</NDC11Code>
    <ProductNDC>85789-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lucemyra</ProprietaryName>
    <NonProprietaryName>Lofexidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260815</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209229</ApplicationNumber>
    <LabelerName>BioCorRx Pharmaceuticals Inc</LabelerName>
    <SubstanceName>LOFEXIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LUCEMYRA is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.</IndicationAndUsage>
    <Description>LUCEMYRA tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1H- imidazole monohydrochloride with a molecular formula of C11H12Cl2N2OHCl. Its molecular weight is 295.6 g/mole and its structural formula is. Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in water, methanol, and ethanol. It is slightly soluble in chloroform and practically insoluble in n-hexane and benzene. LUCEMYRA is available as round, convex-shaped, peach-colored, film-coated tablets for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride, and the following inactive ingredients: 92.6 mg lactose, 12.3 mg citric acid, 1.1 mg povidone, 5.7 mg microcrystalline cellulose, 1.4 mg calcium stearate, 0.7 mg sodium lauryl sulphate, and Opadry OY S 9480 (contains indigo carmine and sunset yellow).</Description>
  </NDC>
  <NDC>
    <NDCCode>41382-002-01</NDCCode>
    <PackageDescription>80 CLOTH in 1 BAG (41382-002-01) </PackageDescription>
    <NDC11Code>41382-0002-01</NDC11Code>
    <ProductNDC>41382-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disinfectant Wipes</ProprietaryName>
    <NonProprietaryName>Disinfectant Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200521</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Jinhua Dubei Maternal &amp; Infant Products Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>36; 9</StrengthNumber>
    <StrengthUnit>mL/801; g/801</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Open the cover whenusing, tear of the adhesive tape, can be exracteduse. use Afer, please fimely reduce the adhesive paste and close the cover to avoid inemal moisure eaporation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72205-181-36</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (72205-181-36)  / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30) </PackageDescription>
    <NDC11Code>72205-0181-36</NDC11Code>
    <ProductNDC>72205-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212772</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg and 801 mg pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in dichloromethane, methanol, soluble in ethanol and practically insoluble in water. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol) and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-182-36</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (72205-182-36)  / 30 TABLET, FILM COATED in 1 BOTTLE (72205-182-30) </PackageDescription>
    <NDC11Code>72205-0182-36</NDC11Code>
    <ProductNDC>72205-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212772</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>801</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg and 801 mg pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in dichloromethane, methanol, soluble in ethanol and practically insoluble in water. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol) and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>72572-801-02</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (72572-801-02)  / 10 mL in 1 VIAL, GLASS (72572-801-01) </PackageDescription>
    <NDC11Code>72572-0801-02</NDC11Code>
    <ProductNDC>72572-801</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190702</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204107</ApplicationNumber>
    <LabelerName>Civica, Inc.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials each containing the equivalent of 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H ,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-001-01</NDCCode>
    <PackageDescription>1 kg in 1 DRUM (64380-001-01)</PackageDescription>
    <NDC11Code>64380-0001-01</NDC11Code>
    <ProductNDC>64380-001</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19970923</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Strides Shasun Limited</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>64380-001-02</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (64380-001-02)</PackageDescription>
    <NDC11Code>64380-0001-02</NDC11Code>
    <ProductNDC>64380-001</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19970923</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Strides Shasun Limited</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>64380-001-04</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (64380-001-04)</PackageDescription>
    <NDC11Code>64380-0001-04</NDC11Code>
    <ProductNDC>64380-001</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19970923</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Strides Shasun Limited</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>64380-001-05</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (64380-001-05)</PackageDescription>
    <NDC11Code>64380-0001-05</NDC11Code>
    <ProductNDC>64380-001</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19970923</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Strides Shasun Limited</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>64380-116-01</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (64380-116-01)  / 177 mL in 1 BOTTLE (64380-116-02) </PackageDescription>
    <NDC11Code>64380-0116-01</NDC11Code>
    <ProductNDC>64380-116</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral</ProprietaryName>
    <NonProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215469</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>17.5; 3.13; 1.6</StrengthNumber>
    <StrengthUnit>g/177mL; g/177mL; g/177mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
    <Description>Sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) is an osmotic laxative and is provided as two bottles in a carton, each bottle containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid monohydrate USP, mixberry flavor, malic acid USP-NF, purified water, sodium benzoate USP-NF, sucralose USP-NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC, purified. The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate, USP. The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each sodium sulfate, potassium sulfate and magnesium sulfate oral solution package also contains a polypropylene mixing container.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-121-01</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (64380-121-01) </PackageDescription>
    <NDC11Code>64380-0121-01</NDC11Code>
    <ProductNDC>64380-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070040</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-121-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (64380-121-02) </PackageDescription>
    <NDC11Code>64380-0121-02</NDC11Code>
    <ProductNDC>64380-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070040</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251116</StartMarketingDatePackage>
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    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
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    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
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    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
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    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
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    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with Metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole tablets and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Metronidazole Tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
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    <IndicationAndUsage>Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids.</IndicationAndUsage>
    <Description>Cyclosporine capsules, USP (modified) is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, USP the active principle in cyclosporine capsules, USP (modified), is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine, USP is designated as [ R-[ R*, R*-( E)]]-cyclic-(L-alanyl-D-alanyl- N-methyl-L-leucyl- N-methyl-L-leucyl- N-methyl-L-valyl-3-hydroxy- N,4-dimethyl-L-2-amino-6-octenoyl-L-α -amino-butyryl- N-methylglycyl- N-methyl-L-leucyl-L-valyl- N-methyl-L-leucyl). Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) are available in 25 mg, 50 mg and 100 mg strengths. Each 25 mg capsule contains. Cyclosporine, USP………………………………………………………………………………25 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Each 50 mg capsule contains. Cyclosporine, USP…………………………………………………………………...50 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Each 100 mg capsule contains. Cyclosporine, USP……………………………………………………………………………...100 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Inactive Ingredients:gelatin, glycerin, propylene glycol, titanium dioxide, ferric oxide black [25 mg and 100 mg], glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil, all-rac-alpha tocopherol [vitamin E synthetic], Ink contains- ammonium hydroxide 28%, iron oxide red, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. The chemical structure of cyclosporine (also known as cyclosporin A) is.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-128-02</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (64380-128-02)  / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (64380-128-01) </PackageDescription>
    <NDC11Code>64380-0128-02</NDC11Code>
    <ProductNDC>64380-128</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclosporine</ProprietaryName>
    <NonProprietaryName>Cyclosporine</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220816</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216046</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>CYCLOSPORINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids.</IndicationAndUsage>
    <Description>Cyclosporine capsules, USP (modified) is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, USP the active principle in cyclosporine capsules, USP (modified), is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine, USP is designated as [ R-[ R*, R*-( E)]]-cyclic-(L-alanyl-D-alanyl- N-methyl-L-leucyl- N-methyl-L-leucyl- N-methyl-L-valyl-3-hydroxy- N,4-dimethyl-L-2-amino-6-octenoyl-L-α -amino-butyryl- N-methylglycyl- N-methyl-L-leucyl-L-valyl- N-methyl-L-leucyl). Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) are available in 25 mg, 50 mg and 100 mg strengths. Each 25 mg capsule contains. Cyclosporine, USP………………………………………………………………………………25 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Each 50 mg capsule contains. Cyclosporine, USP…………………………………………………………………...50 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Each 100 mg capsule contains. Cyclosporine, USP……………………………………………………………………………...100 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Inactive Ingredients:gelatin, glycerin, propylene glycol, titanium dioxide, ferric oxide black [25 mg and 100 mg], glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil, all-rac-alpha tocopherol [vitamin E synthetic], Ink contains- ammonium hydroxide 28%, iron oxide red, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. The chemical structure of cyclosporine (also known as cyclosporin A) is.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-129-02</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (64380-129-02)  / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (64380-129-01) </PackageDescription>
    <NDC11Code>64380-0129-02</NDC11Code>
    <ProductNDC>64380-129</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclosporine</ProprietaryName>
    <NonProprietaryName>Cyclosporine</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220816</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216046</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>CYCLOSPORINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids.</IndicationAndUsage>
    <Description>Cyclosporine capsules, USP (modified) is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, USP the active principle in cyclosporine capsules, USP (modified), is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine, USP is designated as [ R-[ R*, R*-( E)]]-cyclic-(L-alanyl-D-alanyl- N-methyl-L-leucyl- N-methyl-L-leucyl- N-methyl-L-valyl-3-hydroxy- N,4-dimethyl-L-2-amino-6-octenoyl-L-α -amino-butyryl- N-methylglycyl- N-methyl-L-leucyl-L-valyl- N-methyl-L-leucyl). Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) are available in 25 mg, 50 mg and 100 mg strengths. Each 25 mg capsule contains. Cyclosporine, USP………………………………………………………………………………25 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Each 50 mg capsule contains. Cyclosporine, USP…………………………………………………………………...50 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Each 100 mg capsule contains. Cyclosporine, USP……………………………………………………………………………...100 mg. Dehydrated alcohol................ (9.5% w/v or 12.0% v/v). Inactive Ingredients:gelatin, glycerin, propylene glycol, titanium dioxide, ferric oxide black [25 mg and 100 mg], glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil, all-rac-alpha tocopherol [vitamin E synthetic], Ink contains- ammonium hydroxide 28%, iron oxide red, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. The chemical structure of cyclosporine (also known as cyclosporin A) is.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-149-01</NDCCode>
    <PackageDescription>420 mL in 1 BOTTLE, PLASTIC (64380-149-01) </PackageDescription>
    <NDC11Code>64380-0149-01</NDC11Code>
    <ProductNDC>64380-149</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sucralfate</ProprietaryName>
    <NonProprietaryName>Sucralfate</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240710</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216474</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>SUCRALFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Aluminum Complex [EPC], Organometallic Compounds [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.</IndicationAndUsage>
    <Description>Sucralfate Oral Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate Oral Suspension also contains: colloidal silicon dioxide, cherry flavor (containing artificial flavors, benzyl alcohol, lactic acid and maltodextrin), FD&amp;C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion and sorbitol solution. Therapeutic category: antiulcer.</Description>
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