RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>49288-0182-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0182-3)</PackageDescription>
    <NDC11Code>49288-0182-03</NDC11Code>
    <ProductNDC>49288-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mixture Of Standardized Mites</ProprietaryName>
    <NonProprietaryName>Mixture Of Standardized Mites</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19911022</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102225</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE</SubstanceName>
    <StrengthNumber>5000; 5000</StrengthNumber>
    <StrengthUnit>[AU]/mL; [AU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).</IndicationAndUsage>
    <Description>DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0182-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0182-2)</PackageDescription>
    <NDC11Code>49288-0182-02</NDC11Code>
    <ProductNDC>49288-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mixture Of Standardized Mites</ProprietaryName>
    <NonProprietaryName>Mixture Of Standardized Mites</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19911022</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102225</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE</SubstanceName>
    <StrengthNumber>5000; 5000</StrengthNumber>
    <StrengthUnit>[AU]/mL; [AU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).</IndicationAndUsage>
    <Description>DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0182-4</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0182-4)</PackageDescription>
    <NDC11Code>49288-0182-04</NDC11Code>
    <ProductNDC>49288-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mixture Of Standardized Mites</ProprietaryName>
    <NonProprietaryName>Mixture Of Standardized Mites</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19911022</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102225</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE</SubstanceName>
    <StrengthNumber>5000; 5000</StrengthNumber>
    <StrengthUnit>[AU]/mL; [AU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).</IndicationAndUsage>
    <Description>DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0182-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0182-5)</PackageDescription>
    <NDC11Code>49288-0182-05</NDC11Code>
    <ProductNDC>49288-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mixture Of Standardized Mites</ProprietaryName>
    <NonProprietaryName>Mixture Of Standardized Mites</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19911022</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102225</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE</SubstanceName>
    <StrengthNumber>5000; 5000</StrengthNumber>
    <StrengthUnit>[AU]/mL; [AU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).</IndicationAndUsage>
    <Description>DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period.</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-0182-3</NDCCode>
    <PackageDescription>750 PELLET in 1 PACKAGE (15631-0182-3) </PackageDescription>
    <NDC11Code>15631-0182-03</NDC11Code>
    <ProductNDC>15631-0182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eupatorium Perfoliatum</ProprietaryName>
    <NonProprietaryName>Eupatorium Perfoliatum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151002</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>EUPATORIUM PERFOLIATUM FLOWERING TOP</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-0182-3</NDCCode>
    <PackageDescription>5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0182-3)  &gt; 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0182-1)  &gt; 2 mL in 1 SYRINGE (17856-0182-2) </PackageDescription>
    <NDC11Code>17856-0182-03</NDC11Code>
    <ProductNDC>17856-0182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210518</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce fever and for the temporary relief of minor aches and pains due to: 1 headache , 2 muscular aches , 3 backache , 4 minor pain of arthritis , 5 the common cold, 6 toothache , 7 premenstrual and menstrual cramps. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37662-0182-3</NDCCode>
    <PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0182-3) </PackageDescription>
    <NDC11Code>37662-0182-03</NDC11Code>
    <ProductNDC>37662-0182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Carboneum Sulphuratum</ProprietaryName>
    <NonProprietaryName>Carboneum Sulphuratum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220526</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>CARBON DISULFIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>[hp_M]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220526</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>38779-0182-3</NDCCode>
    <PackageDescription>5 g in 1 VIAL (38779-0182-3) </PackageDescription>
    <NDC11Code>38779-0182-03</NDC11Code>
    <ProductNDC>38779-0182</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150803</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Medisca Inc.</LabelerName>
    <SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-09-29</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>03-AUG-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>50090-0182-3</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (50090-0182-3) </PackageDescription>
    <NDC11Code>50090-0182-03</NDC11Code>
    <ProductNDC>50090-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methocarbamol</ProprietaryName>
    <NonProprietaryName>Methocarbamol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090200</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>METHOCARBAMOL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
    <Description>Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>58443-0182-3</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (58443-0182-3) </PackageDescription>
    <NDC11Code>58443-0182-03</NDC11Code>
    <ProductNDC>58443-0182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lifecell</ProprietaryName>
    <ProprietaryNameSuffix>Bb Cream Hydrating Anti-oxidant Beauty Balm Broad Spectrum Spf 30 Light</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140116</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Prime Enterprises, Inc.</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>29.19; 29.19</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59762-0182-3</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (59762-0182-3)  &gt; 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59762-0182-03</NDC11Code>
    <ProductNDC>59762-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110602</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020699</ApplicationNumber>
    <LabelerName>Greenstone LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60505-0182-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60505-0182-3)</PackageDescription>
    <NDC11Code>60505-0182-03</NDC11Code>
    <ProductNDC>60505-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076882</ApplicationNumber>
    <LabelerName>Apotex Corp</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>70518-0182-3</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (70518-0182-3) </PackageDescription>
    <NDC11Code>70518-0182-03</NDC11Code>
    <ProductNDC>70518-0182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077829</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-0182-3</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (71335-0182-3) </PackageDescription>
    <NDC11Code>71335-0182-03</NDC11Code>
    <ProductNDC>71335-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076143</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.21 g/mol. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white to off-white crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride is supplied for oral administration as 75-mg (orange) and 100-mg (purple) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients:. 75-mg tablet –colloidal silicon dioxide, crospovidone, FD&amp;C Yellow #6 Aluminum Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. 100-mg tablet –colloidal silicon dioxide, crospovidone, D&amp;C Red #7 Calcium Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>80425-0182-3</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (80425-0182-3) </PackageDescription>
    <NDC11Code>80425-0182-03</NDC11Code>
    <ProductNDC>80425-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204989</ApplicationNumber>
    <LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C Red 40, D&amp;C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&amp;C Yellow 10, and FD&amp;C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0182-01</NDCCode>
    <PackageDescription>10 AMPULE in 1 PACKAGE (0078-0182-01)  / 1 mL in 1 AMPULE (0078-0182-61) </PackageDescription>
    <NDC11Code>00078-0182-01</NDC11Code>
    <ProductNDC>0078-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19881021</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019667</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19881021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sandostatin Injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).</IndicationAndUsage>
    <Description>Sandostatin Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Sandostatin Injection is available as sterile 1-mL ampuls in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate). Each ampul also contains lactic acid, USP (3.4 mg), mannitol, USP (45 mg), sodium bicarbonate, USP (quantity sufficient to pH 4.2 ± 0.3), water for injection, USP (quantity sufficient to 1 mL). Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0182-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0182-01) </PackageDescription>
    <NDC11Code>00378-0182-01</NDC11Code>
    <ProductNDC>0378-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19851119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070213</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19851119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
    <Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake and FD&amp;C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0182-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0182-10) </PackageDescription>
    <NDC11Code>00378-0182-10</NDC11Code>
    <ProductNDC>0378-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19851119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070213</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19851119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
    <Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake and FD&amp;C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0182-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-01)  / 52.6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00409-0182-01</NDC11Code>
    <ProductNDC>0409-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gemcitabine</ProprietaryName>
    <NonProprietaryName>Gemcitabine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20110822</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200795</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>38</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
    <Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙ HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0182-25</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-25)  / 52.6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00409-0182-25</NDC11Code>
    <ProductNDC>0409-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gemcitabine</ProprietaryName>
    <NonProprietaryName>Gemcitabine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130729</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200795</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>38</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
    <Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>10096-0182-1</NDCCode>
    <PackageDescription>125 mL in 1 TUBE (10096-0182-1) </PackageDescription>
    <NDC11Code>10096-0182-01</NDC11Code>
    <ProductNDC>10096-0182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clearskin</ProprietaryName>
    <ProprietaryNameSuffix>Blackhead Eliminating Cleanser</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>New Avon LLC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 for the treatment of acne, 2 clears up blackheads, 3 helps prevent new blackheads from forming.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10544-182-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (10544-182-30)</PackageDescription>
    <NDC11Code>10544-0182-30</NDC11Code>
    <ProductNDC>10544-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077045</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Citalopram Tablets USP are indicated for the treatment of depression. The efficacy of citalopram tablets in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms:  depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram tablets in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Citalopram hydrobromide is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available only in tablet dosage form. Citalopram Tablets USP, 10 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 10 mg citalopram base. Citalopram Tablets USP, 20 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 20 mg of citalopram base. Citalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets in strengths equivalent to 40 mg of citalopram base. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-182-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (10544-182-90)</PackageDescription>
    <NDC11Code>10544-0182-90</NDC11Code>
    <ProductNDC>10544-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077045</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Citalopram Tablets USP are indicated for the treatment of depression. The efficacy of citalopram tablets in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms:  depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram tablets in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Citalopram hydrobromide is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available only in tablet dosage form. Citalopram Tablets USP, 10 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 10 mg citalopram base. Citalopram Tablets USP, 20 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 20 mg of citalopram base. Citalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets in strengths equivalent to 40 mg of citalopram base. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>11489-182-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (11489-182-01)  / 50 g in 1 JAR</PackageDescription>
    <NDC11Code>11489-0182-01</NDC11Code>
    <ProductNDC>11489-182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>No7 Lift And Luminate Triple Action Day Cream Spf 30</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210817</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>BCM Ltd</LabelerName>
    <SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTISALATE</SubstanceName>
    <StrengthNumber>1.5; 3.75; 2.5</StrengthNumber>
    <StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses.</IndicationAndUsage>
    <Description>No7 Lift &amp; Luminate TRIPLE ACTION Anti-Ageing Skincare System. 3 key age defying results. Wrinkles appear visbly reduced. Noticeably firmer feeling skin. A more even skin tone. Younger looking skin in 2 weeks. 50 ml e 1.69 Fl. Oz. Day Cream. TRIPLE ACTION results, instant hydration for visibly younger looking skin. Combining the protective power of SPF 30, our unique Double Defence technology and our No7 age defying ingredients. Ther perfect partner to your No7 Lift &amp; Luminate TRIPLE ACTION serum, this day cream works to visibly reduce the appearance of 3 key signs of ageing: winkles appear visibly reduced, skin feels firmer and skin tone looks more even in 2 weeks.</Description>
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  <NDC>
    <NDCCode>13668-182-05</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (13668-182-05) </PackageDescription>
    <NDC11Code>13668-0182-05</NDC11Code>
    <ProductNDC>13668-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201619</ApplicationNumber>
    <LabelerName>Torrent 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>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) 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. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):o in adults with primary hypercholesterolemia.o and slow the progression of atherosclerosis in adults.o in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).o in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:o Primary dysbetalipoproteinemia.o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP 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 USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. 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: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Additionally, the 5 mg tablet contains ferric oxide yellow and the 10 mg, 20 mg and 40 mg tablets contain ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-182-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE (13668-182-30) </PackageDescription>
    <NDC11Code>13668-0182-30</NDC11Code>
    <ProductNDC>13668-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201619</ApplicationNumber>
    <LabelerName>Torrent 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>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) 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. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):o in adults with primary hypercholesterolemia.o and slow the progression of atherosclerosis in adults.o in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).o in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:o Primary dysbetalipoproteinemia.o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP 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 USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. 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: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Additionally, the 5 mg tablet contains ferric oxide yellow and the 10 mg, 20 mg and 40 mg tablets contain ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-182-90</NDCCode>
    <PackageDescription>90 TABLET, COATED in 1 BOTTLE (13668-182-90) </PackageDescription>
    <NDC11Code>13668-0182-90</NDC11Code>
    <ProductNDC>13668-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201619</ApplicationNumber>
    <LabelerName>Torrent 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>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) 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. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):o in adults with primary hypercholesterolemia.o and slow the progression of atherosclerosis in adults.o in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).o in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:o Primary dysbetalipoproteinemia.o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP 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 USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. 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: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Additionally, the 5 mg tablet contains ferric oxide yellow and the 10 mg, 20 mg and 40 mg tablets contain ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>13734-182-60</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13734-182-60)  / 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>13734-0182-60</NDC11Code>
    <ProductNDC>13734-182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nars Pure Radiant Tinted Moisturizer</ProprietaryName>
    <ProprietaryNameSuffix>Terre Neuve</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>NARS Cosmetics</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>4.044; 3.996</StrengthNumber>
    <StrengthUnit>g/50mL; g/50mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunbun. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-182-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-182-01) </PackageDescription>
    <NDC11Code>16714-0182-01</NDC11Code>
    <ProductNDC>16714-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paroxetine</ProprietaryName>
    <NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078406</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of:  : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
    <Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&amp;C Red #30 Aluminum Lake. 30 mg tablet contains FD&amp;C Blue #2 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-182-02</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16714-182-02) </PackageDescription>
    <NDC11Code>16714-0182-02</NDC11Code>
    <ProductNDC>16714-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paroxetine</ProprietaryName>
    <NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078406</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of:  : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
    <Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&amp;C Red #30 Aluminum Lake. 30 mg tablet contains FD&amp;C Blue #2 Aluminum Lake.</Description>
  </NDC>
</NDCList>