RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>21922-046-41</NDCCode>
    <PackageDescription>1 APPLICATOR in 1 CARTON (21922-046-41)  / 5 g in 1 APPLICATOR</PackageDescription>
    <NDC11Code>21922-0046-41</NDC11Code>
    <ProductNDC>21922-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole Vaginal Gel</ProprietaryName>
    <NonProprietaryName>Metronidazole Vaginal Gel, 1.3 %</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20240319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216795</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>65</StrengthNumber>
    <StrengthUnit>mg/5g</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.</IndicationAndUsage>
    <Description>Metronidazole vaginal gel contains 1.3% metronidazole, USP in a single-dose prefilled disposable applicator. It is intended for intravaginal use. Metronidazole is a nitroimidazole antimicrobial. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. Its structural formula is. The molecular formula is C6H9N3O3 with a molecular weight of 171.16. Metronidazole vaginal gel is an aqueous gel containing metronidazole at a concentration of 13 mg/g (1.3%). The gel is formulated at pH 4.0. The gel also contains benzyl alcohol, methyl paraben, polycarbophil, polyethylene glycol 400, propylene glycol, propyl paraben, and purified water. Each applicator contains approximately 65 mg of metronidazole in 5 g of vaginal gel.</Description>
  </NDC>
  <NDC>
    <NDCCode>52000-046-41</NDCCode>
    <PackageDescription>2 PATCH in 1 POUCH (52000-046-41)  / 8.5 g in 1 PATCH</PackageDescription>
    <NDC11Code>52000-0046-41</NDC11Code>
    <ProductNDC>52000-046</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Relief Hot Patch</ProprietaryName>
    <NonProprietaryName>Menthol And Capsaicin</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200323</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Universal Distribution Center LLC</LabelerName>
    <SubstanceName>MENTHOL, UNSPECIFIED FORM; CAPSAICIN</SubstanceName>
    <StrengthNumber>30; .83</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves minor pain associated with: 1 arthritis  simple backache  bursitis  tendonitis  muscle strains  bruises  cramps.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66843-046-41</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BLISTER PACK (66843-046-41)  &gt; 1 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>66843-0046-41</NDC11Code>
    <ProductNDC>66843-046</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Scholls Wellness Company Llc</ProprietaryName>
    <ProprietaryNameSuffix>Liquid Corn And Callus Remover</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358F</ApplicationNumber>
    <LabelerName>Scapa Tapes North America LLC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>1.7</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. for the removal of corns and calluses  relieves pain by removing corns and calluses.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72146-046-00</NDCCode>
    <PackageDescription>3785.41 mL in 1 BOTTLE (72146-046-00) </PackageDescription>
    <NDC11Code>72146-0046-00</NDC11Code>
    <ProductNDC>72146-046</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Global Household Antibacterial Hand Orange</ProprietaryName>
    <NonProprietaryName>Chloroxylenol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200914</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Target Price Inc</LabelerName>
    <SubstanceName>CHLOROXYLENOL</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21922-068-43</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (21922-068-43)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
    <NDC11Code>21922-0068-43</NDC11Code>
    <ProductNDC>21922-068</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
    <NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204087</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
    <Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-068-44</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (21922-068-44)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
    <NDC11Code>21922-0068-44</NDC11Code>
    <ProductNDC>21922-068</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
    <NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204087</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
    <Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-068-45</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (21922-068-45)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
    <NDC11Code>21922-0068-45</NDC11Code>
    <ProductNDC>21922-068</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
    <NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204087</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
    <Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-068-46</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (21922-068-46)  *  20 g in 1 JAR (21922-067-62)  *  40 g in 1 JAR (21922-067-41)  *  28 g in 1 BOTTLE, PUMP (21922-067-39)  *  40 g in 1 BOTTLE, PUMP (21922-067-42)  *  10 g in 1 BOTTLE (21922-066-12)  *  7 g in 1 BOTTLE (21922-066-37)  *  5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
    <NDC11Code>21922-0068-46</NDC11Code>
    <ProductNDC>21922-068</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
    <NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20251007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204087</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
    <Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>13533-800-40</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (13533-800-40)  &gt; 400 mL in 1 VIAL, GLASS (13533-800-41) </PackageDescription>
    <NDC11Code>13533-0800-40</NDC11Code>
    <ProductNDC>13533-800</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gamunex-c</ProprietaryName>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101013</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125046</ApplicationNumber>
    <LabelerName>GRIFOLS USA, LLC</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMUNEX-C is an immune globulin injection (human) 10% liquid that is indicated for the treatment of.</IndicationAndUsage>
    <Description>GAMUNEX-C is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous and subcutaneous (PI indication only) administration. GAMUNEX-C is clear to opalescent, and colorless to pale yellow. GAMUNEX-C consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMUNEX-C is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMUNEX-C contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMUNEX-C doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMUNEX-C. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects.(21) Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects.(22) Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMUNEX-C would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMUNEX-C is 4.0–4.5. GAMUNEX-C contains no preservative. GAMUNEX-C is not made with natural rubber latex. GAMUNEX-C is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMUNEX-C is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration and may be administered subcutaneously in treatment of PI. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.(23). Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(23). Several of the individual production steps in the GAMUNEX-C manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10).  These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>60290-046-01</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (60290-046-01) </PackageDescription>
    <NDC11Code>60290-0046-01</NDC11Code>
    <ProductNDC>60290-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207626</ApplicationNumber>
    <LabelerName>Umedica Laboratories USA Inc.</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets is indicated. : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 3 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E) with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a White or almost white, hygroscopic powder that is freely soluble in methylene chloride, slightly soluble in water practically insoluble in anhydrous ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone USP, hypromellose USP, iron oxide red NF, lactose monohydrate USP, magnesium stearate USP, microcrystalline cellulose USP, sodium bicarbonate powder NF, titanium dioxide USP, triacetin USP.</Description>
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    <IndicationAndUsage>Rosuvastatin tablets is indicated. : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 3 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E) with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a White or almost white, hygroscopic powder that is freely soluble in methylene chloride, slightly soluble in water practically insoluble in anhydrous ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone USP, hypromellose USP, iron oxide red NF, lactose monohydrate USP, magnesium stearate USP, microcrystalline cellulose USP, sodium bicarbonate powder NF, titanium dioxide USP, triacetin USP.</Description>
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    <IndicationAndUsage>Rosuvastatin tablets is indicated. : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 3 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E) with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a White or almost white, hygroscopic powder that is freely soluble in methylene chloride, slightly soluble in water practically insoluble in anhydrous ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone USP, hypromellose USP, iron oxide red NF, lactose monohydrate USP, magnesium stearate USP, microcrystalline cellulose USP, sodium bicarbonate powder NF, titanium dioxide USP, triacetin USP.</Description>
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    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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    <IndicationAndUsage>Rosuvastatin tablets is indicated. : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 3 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E) with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a White or almost white, hygroscopic powder that is freely soluble in methylene chloride, slightly soluble in water practically insoluble in anhydrous ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone USP, hypromellose USP, iron oxide red NF, lactose monohydrate USP, magnesium stearate USP, microcrystalline cellulose USP, sodium bicarbonate powder NF, titanium dioxide USP, triacetin USP.</Description>
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    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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    <IndicationAndUsage>Rosuvastatin tablets is indicated. : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 3 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E) with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a White or almost white, hygroscopic powder that is freely soluble in methylene chloride, slightly soluble in water practically insoluble in anhydrous ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone USP, hypromellose USP, iron oxide red NF, lactose monohydrate USP, magnesium stearate USP, microcrystalline cellulose USP, sodium bicarbonate powder NF, titanium dioxide USP, triacetin USP.</Description>
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    <ProductNDC>63187-046</ProductNDC>
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    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-18</LastUpdate>
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    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
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    <SubstanceName>CEPHALEXIN</SubstanceName>
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    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
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    <LastUpdate>2022-05-18</LastUpdate>
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    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
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    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
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    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
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    <ProductNDC>63187-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065229</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-046-21</NDCCode>
    <PackageDescription>21 CAPSULE in 1 BOTTLE (63187-046-21) </PackageDescription>
    <NDC11Code>63187-0046-21</NDC11Code>
    <ProductNDC>63187-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065229</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-046-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (63187-046-28) </PackageDescription>
    <NDC11Code>63187-0046-28</NDC11Code>
    <ProductNDC>63187-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065229</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-046-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (63187-046-30) </PackageDescription>
    <NDC11Code>63187-0046-30</NDC11Code>
    <ProductNDC>63187-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065229</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-046-40</NDCCode>
    <PackageDescription>40 CAPSULE in 1 BOTTLE (63187-046-40) </PackageDescription>
    <NDC11Code>63187-0046-40</NDC11Code>
    <ProductNDC>63187-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065229</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S  H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&amp;C Yellow 10, FD&amp;C Blue 1, FD&amp;C Green 3, FD&amp;C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69844-046-01</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69844-046-01) </PackageDescription>
    <NDC11Code>69844-0046-01</NDC11Code>
    <ProductNDC>69844-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211088</ApplicationNumber>
    <LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1   Parkinson's disease (PD) (1.1), 2   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl·H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg. Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, povidone, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>71209-046-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71209-046-01) </PackageDescription>
    <NDC11Code>71209-0046-01</NDC11Code>
    <ProductNDC>71209-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207453</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. , 2  As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 3 As an adjunct to diet for the treatment of adults with: .</IndicationAndUsage>
    <Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium  is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin Tablets, for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: 5 mg tablet - microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate, hypromellose, titanium dioxide, triacetin, iron oxide yellow, sodium hydrogen carbonate; 10 mg, 20 mg, 40 mg tablet - microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate, hypromellose, titanium dioxide, triacetin, iron oxide red, sodium hydrogen carbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-001-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21922-001-01)  / 60 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21922-0001-01</NDC11Code>
    <ProductNDC>21922-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide</ProprietaryName>
    <NonProprietaryName>Fluocinonide Topical Solution Usp, 0.05%</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190419</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209699</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21922-002-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21922-002-01)  / 60 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21922-0002-01</NDC11Code>
    <ProductNDC>21922-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phoaphate Topical Solution Usp, 1%</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate Topical Solution Usp, 1%</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209914</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate topical solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
    <Description>Clindamycin phosphate topical solution USP, 1% contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter.Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)–chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-002-21</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21922-002-21)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21922-0002-21</NDC11Code>
    <ProductNDC>21922-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phoaphate Topical Solution Usp, 1%</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate Topical Solution Usp, 1%</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209914</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate topical solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
    <Description>Clindamycin phosphate topical solution USP, 1% contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter.Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)–chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-003-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21922-003-01)  / 60 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21922-0003-01</NDC11Code>
    <ProductNDC>21922-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinolone Acetonide Topical Solution Usp, 0.01%</ProprietaryName>
    <NonProprietaryName>Fluocinolone Acetonide Topical Solution Usp, 0.01%</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209913</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluocinolone acetonide topical solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Fluocinolone acetonide topical solution, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1, 4-diene-3, 20-dione, 6, 9-difluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis (oxy)]-, (6α, 11β, 16α)-. It has the following chemical structure. Fluocinolone acetonide topical solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water-washable base of anhydrous citric acid and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-004-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-004-04)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0004-04</NDC11Code>
    <ProductNDC>21922-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desonide Ointment, 0.05%</ProprietaryName>
    <NonProprietaryName>Desonide Ointment, 0.05%</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210998</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desonide ointment USP, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
    <Description>Desonide ointment USP, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide ointment USP, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is white to off-white powder. The solubility of desonide in distilled water saturated with the ether is 184 mg/L. Each gram of desonide ointment USP, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-004-07</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-004-07)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0004-07</NDC11Code>
    <ProductNDC>21922-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desonide Ointment, 0.05%</ProprietaryName>
    <NonProprietaryName>Desonide Ointment, 0.05%</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210998</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desonide ointment USP, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
    <Description>Desonide ointment USP, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide ointment USP, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is white to off-white powder. The solubility of desonide in distilled water saturated with the ether is 184 mg/L. Each gram of desonide ointment USP, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum.</Description>
  </NDC>
</NDCList>