RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>53002-1440-0</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (53002-1440-0) </PackageDescription>
    <NDC11Code>53002-1440-00</NDC11Code>
    <ProductNDC>53002-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091624</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Atorvastatin Calcium Tablets are a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-1440-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-1440-3) </PackageDescription>
    <NDC11Code>53002-1440-03</NDC11Code>
    <ProductNDC>53002-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091624</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Atorvastatin Calcium Tablets are a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-1440-9</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (53002-1440-9) </PackageDescription>
    <NDC11Code>53002-1440-09</NDC11Code>
    <ProductNDC>53002-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091624</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Atorvastatin Calcium Tablets are a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>17228-2730-0</NDCCode>
    <PackageDescription>1440 SYRINGE in 1 BOX (17228-2730-0)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17228-2730-00</NDC11Code>
    <ProductNDC>17228-2730</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Benralizumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20211215</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>AstraZeneca AB</LabelerName>
    <SubstanceName>BENRALIZUMAB</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-DEC-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>49706-1440-0</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (49706-1440-0)</PackageDescription>
    <NDC11Code>49706-1440-00</NDC11Code>
    <ProductNDC>49706-1440</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ciclopirox</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20100108</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Erregierre SpA</LabelerName>
    <SubstanceName>CICLOPIROX</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2018-02-15</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>50090-6088-0</NDCCode>
    <PackageDescription>1440 CAPSULE, LIQUID FILLED in 1 CASE (50090-6088-0) </PackageDescription>
    <NDC11Code>50090-6088-00</NDC11Code>
    <ProductNDC>50090-6088</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gas Relief</ProprietaryName>
    <ProprietaryNameSuffix>Ultra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200724</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves bloating, pressure, or fullness commonly referred to as gas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51927-1440-0</NDCCode>
    <PackageDescription>1 kg in 1 CONTAINER (51927-1440-0) </PackageDescription>
    <NDC11Code>51927-1440-00</NDC11Code>
    <ProductNDC>51927-1440</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Erythromycin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130627</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Professional Compounding Centers of America dba PCCA</LabelerName>
    <SubstanceName>ERYTHROMYCIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-JUN-13</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>70518-1440-0</NDCCode>
    <PackageDescription>30 TABLET, SUGAR COATED in 1 BLISTER PACK (70518-1440-0) </PackageDescription>
    <NDC11Code>70518-1440-00</NDC11Code>
    <ProductNDC>70518-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, SUGAR COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180927</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA084113</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazines [CS],Phenothiazine [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180927</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>22840-1440-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1440-2) </PackageDescription>
    <NDC11Code>22840-1440-02</NDC11Code>
    <ProductNDC>22840-1440</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Australian Pine Beefwood Pollen</ProprietaryName>
    <NonProprietaryName>Casuarina Equisetifolia</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>CASUARINA EQUISETIFOLIA POLLEN</SubstanceName>
    <StrengthNumber>40000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
    <Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-1440-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-1440-4) </PackageDescription>
    <NDC11Code>22840-1440-04</NDC11Code>
    <ProductNDC>22840-1440</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Australian Pine Beefwood Pollen</ProprietaryName>
    <NonProprietaryName>Casuarina Equisetifolia</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>CASUARINA EQUISETIFOLIA POLLEN</SubstanceName>
    <StrengthNumber>40000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
    <Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1440-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1440-1)</PackageDescription>
    <NDC11Code>36987-1440-01</NDC11Code>
    <ProductNDC>36987-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sweet Corn</ProprietaryName>
    <NonProprietaryName>Sweet Corn</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>CORN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1440-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1440-2)</PackageDescription>
    <NDC11Code>36987-1440-02</NDC11Code>
    <ProductNDC>36987-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sweet Corn</ProprietaryName>
    <NonProprietaryName>Sweet Corn</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>CORN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1440-3</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1440-3)</PackageDescription>
    <NDC11Code>36987-1440-03</NDC11Code>
    <ProductNDC>36987-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sweet Corn</ProprietaryName>
    <NonProprietaryName>Sweet Corn</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>CORN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1440-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1440-4)</PackageDescription>
    <NDC11Code>36987-1440-04</NDC11Code>
    <ProductNDC>36987-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sweet Corn</ProprietaryName>
    <NonProprietaryName>Sweet Corn</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>CORN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-1502-0</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (50090-1502-0)  / 1 mL in 1 SYRINGE (50090-1502-9) </PackageDescription>
    <NDC11Code>50090-1502-00</NDC11Code>
    <ProductNDC>50090-1502</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Havrix</ProprietaryName>
    <NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103475</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>1440</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.</IndicationAndUsage>
    <Description>HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>51662-1440-1</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (51662-1440-1) </PackageDescription>
    <NDC11Code>51662-1440-01</NDC11Code>
    <ProductNDC>51662-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyanocobalamin</ProprietaryName>
    <NonProprietaryName>Cyanocobalamin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20200129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA080737</ApplicationNumber>
    <LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
    <SubstanceName>CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see PRECAUTIONS-Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test ( DOSAGE &amp; ADMINISTRATION-Schilling test).</IndicationAndUsage>
    <Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
  </NDC>
  <NDC>
    <NDCCode>55045-3841-1</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (55045-3841-1)  &gt; 1 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55045-3841-01</NDC11Code>
    <ProductNDC>55045-3841</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Havrix</ProprietaryName>
    <NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103475</ApplicationNumber>
    <LabelerName>Dispensing Solutions, Inc.</LabelerName>
    <SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>1440</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.</IndicationAndUsage>
    <Description>HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5-mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. The vial stopper does not contain latex. [See How Supplied/Storage and Handling (16).].</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-826-52</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (58160-826-52)  / 1 mL in 1 SYRINGE (58160-826-43) </PackageDescription>
    <NDC11Code>58160-0826-52</NDC11Code>
    <ProductNDC>58160-826</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Havrix</ProprietaryName>
    <NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103475</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>1440</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.</IndicationAndUsage>
    <Description>HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>67296-1440-3</NDCCode>
    <PackageDescription>3 TABLET, FILM COATED in 1 BOTTLE (67296-1440-3) </PackageDescription>
    <NDC11Code>67296-1440-03</NDC11Code>
    <ProductNDC>67296-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210330</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090513</ApplicationNumber>
    <LabelerName>Redpharm Drug, Inc.</LabelerName>
    <SubstanceName>EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HIV-1 Treatment ( 1.1). Emtricitabine and tenofovir disoproxil fumarate tablets are a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. .</IndicationAndUsage>
    <Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2 R,5 S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.24. It has the following structural formula:. FTC is a white to off-white powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19H 30N 5O 10P  C 4H 4O 4 and a molecular weight of 635.52. It has the following structural formula:. Tenofovir disoproxil fumarate is a white to off-white, crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film-coated tablet contains 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets also include the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, pregelatinized starch (gluten free), and magnesium stearate. The tablets are coated with Opadry II White 32K18425, which contains lactose monohydrate, hypromellose 15cP, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>67296-1440-7</NDCCode>
    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (67296-1440-7) </PackageDescription>
    <NDC11Code>67296-1440-07</NDC11Code>
    <ProductNDC>67296-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210330</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090513</ApplicationNumber>
    <LabelerName>Redpharm Drug, Inc.</LabelerName>
    <SubstanceName>EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HIV-1 Treatment ( 1.1). Emtricitabine and tenofovir disoproxil fumarate tablets are a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. .</IndicationAndUsage>
    <Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2 R,5 S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.24. It has the following structural formula:. FTC is a white to off-white powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19H 30N 5O 10P  C 4H 4O 4 and a molecular weight of 635.52. It has the following structural formula:. Tenofovir disoproxil fumarate is a white to off-white, crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film-coated tablet contains 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets also include the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, pregelatinized starch (gluten free), and magnesium stearate. The tablets are coated with Opadry II White 32K18425, which contains lactose monohydrate, hypromellose 15cP, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>68258-8912-9</NDCCode>
    <PackageDescription>1 mL in 1 VIAL (68258-8912-9)</PackageDescription>
    <NDC11Code>68258-8912-09</NDC11Code>
    <ProductNDC>68258-8912</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Havrix</ProprietaryName>
    <NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103475</ApplicationNumber>
    <LabelerName>Dispensing Solutions, Inc.</LabelerName>
    <SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>1440</StrengthNumber>
    <StrengthUnit>[iU]/mL</StrengthUnit>
    <Pharm_Classes>Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.</IndicationAndUsage>
    <Description>HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5-mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. The vial stopper does not contain latex. [See How Supplied/Storage and Handling (16).].</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-1440-1</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71335-1440-1) </PackageDescription>
    <NDC11Code>71335-1440-01</NDC11Code>
    <ProductNDC>71335-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206434</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. 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 (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of  0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD &amp; C yellow No. 6, FD &amp; C red No. 40, and FD &amp; C blue No.1. Rosuvastatin tablets, USP meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-1440-2</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71335-1440-2) </PackageDescription>
    <NDC11Code>71335-1440-02</NDC11Code>
    <ProductNDC>71335-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206434</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. 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 (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of  0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD &amp; C yellow No. 6, FD &amp; C red No. 40, and FD &amp; C blue No.1. Rosuvastatin tablets, USP meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-1440-3</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71335-1440-3) </PackageDescription>
    <NDC11Code>71335-1440-03</NDC11Code>
    <ProductNDC>71335-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206434</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. 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 (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of  0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD &amp; C yellow No. 6, FD &amp; C red No. 40, and FD &amp; C blue No.1. Rosuvastatin tablets, USP meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-1440-4</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (71335-1440-4) </PackageDescription>
    <NDC11Code>71335-1440-04</NDC11Code>
    <ProductNDC>71335-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206434</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. 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 (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of  0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: For 5 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, and ferric oxide yellow. For 10, 20 and 40 mg: Each film coated tablet contains: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD &amp; C yellow No. 6, FD &amp; C red No. 40, and FD &amp; C blue No.1. Rosuvastatin tablets, USP meet USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>84988-1440-1</NDCCode>
    <PackageDescription>1000 mL in 1 BAG (84988-1440-1) </PackageDescription>
    <NDC11Code>84988-1440-01</NDC11Code>
    <ProductNDC>84988-1440</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride Injection, Solution</ProprietaryName>
    <NonProprietaryName>Sodium Chloride Injection</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20241126</StartMarketingDate>
    <EndMarketingDate>20260212</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
    <LabelerName>HK INNO.N CORPORATION</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>g/1000mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241126</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260212</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures. Storage: Store at room temperature 20°C/68°F. to 25°C/77°F. Medication Administration: Contains medication port and administration port; Twist off shield, left side. These highlights do not include all the information needed to use Sodium Chloride 0.9% Injection. See full prescribing information for Chloride 0.9% Injection. This product is an unapproved product for use in urgent drug shortage” (code C101533).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>53002-0060-0</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-0060-0) </PackageDescription>
    <NDC11Code>53002-0060-00</NDC11Code>
    <ProductNDC>53002-0060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201506</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&amp;C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-0061-0</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-0061-0) </PackageDescription>
    <NDC11Code>53002-0061-00</NDC11Code>
    <ProductNDC>53002-0061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090682</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1)  : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster   .</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&amp;C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-0062-0</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-0062-0) </PackageDescription>
    <NDC11Code>53002-0062-00</NDC11Code>
    <ProductNDC>53002-0062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir</ProprietaryName>
    <NonProprietaryName>Valacyclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203047</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (1.1)   Cold Sores (Herpes Labialis)   Genital Herpes      Treatment in immunocompetent patients (initial or recurrent episode)      Suppression in immunocompetent or HIV-infected patients      Reduction of transmission   Herpes Zoster  Pediatric Patients (1.2)   Cold Sores (Herpes Labialis)   Chickenpox  Limitations of Use (1.3)   The efficacy and safety of valacyclovir tablets, USP have not been    established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&amp;C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-0270-0</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (53002-0270-0) </PackageDescription>
    <NDC11Code>53002-0270-00</NDC11Code>
    <ProductNDC>53002-0270</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203834</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&amp;C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:.</Description>
  </NDC>
</NDCList>