{
"NDC": [
{
"NDCCode": "49288-0176-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0176-3)",
"NDC11Code": "49288-0176-03",
"ProductNDC": "49288-0176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
"NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920206",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102224",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "3000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "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]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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).",
"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."
},
{
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"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0176-4)",
"NDC11Code": "49288-0176-04",
"ProductNDC": "49288-0176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
"NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920206",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102224",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "3000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "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]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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).",
"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."
},
{
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"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0176-5)",
"NDC11Code": "49288-0176-05",
"ProductNDC": "49288-0176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
"NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920206",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102224",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "3000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "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]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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).",
"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."
},
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"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryName": "Carboneum Sulphuratum",
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"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CARBON DISULFIDE",
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"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-05-28",
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"StartMarketingDatePackage": "20220526",
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},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
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"StartMarketingDate": "20000101",
"MarketingCategoryName": "ANDA",
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"LabelerName": "A-S Medication Solutions",
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"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N"
},
{
"NDCCode": "51552-0176-3",
"PackageDescription": "25 g in 1 CONTAINER (51552-0176-3)",
"NDC11Code": "51552-0176-03",
"ProductNDC": "51552-0176",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190226",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "70000-0176-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (70000-0176-3) > 250 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "70000-0176-03",
"ProductNDC": "70000-0176",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072096",
"LabelerName": "Cardinal Health 110, LLC. dba Leader",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161130",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0176-3",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-0176-3) ",
"NDC11Code": "71335-0176-03",
"ProductNDC": "71335-0176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221012",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "0338-0176-01",
"PackageDescription": "30 BAG in 1 CARTON (0338-0176-01) / 100 mL in 1 BAG",
"NDC11Code": "00338-0176-01",
"ProductNDC": "0338-0176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19921207",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020179",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221207",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 13 mm or 20 mm closure.",
"Description": "Dextrose Injection, 5% USP is a clear, sterile, non-pyrogenic solution of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)]. Flexible containers, designed to facilitate admixture, are available in 50 mL and 100 mL sizes. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The Mini-Bag Plus Container System is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered or liquid (up to 10 mL) drug vial having a 13mm or 20mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of a powdered or a liquid (up to 10mL) drug. The Mini-Bag Plus product mechanically prohibits the transfer of contaminants into and out of the system during and after docking, minimizing environmental and personal exposure. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an infusion solution for delivery to the patient. The VIAFLEX Plastic Container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "10370-176-11",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-11) ",
"NDC11Code": "10370-0176-11",
"ProductNDC": "10370-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvoxamine Maleate",
"NonProprietaryName": "Fluvoxamine Maleate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091476",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "FLUVOXAMINE MALEATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130313",
"SamplePackage": "N",
"IndicationAndUsage": "Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (1). Efficacy was demonstrated in: 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults (14.1)., 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (14.1, 14.3)., 3 One maintenance study with IR fluvoxamine tablets (14.2).",
"Description": "Fluvoxamine maleate extended-release capsules are an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as 5-methoxy-4’-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3C4H4O4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, each capsule contains the following inactive ingredients: black iron oxide, dehydrated alcohol, ethylcellulose, gelatin, hydroxypropyl cellulose, isopropyl alcohol, povidone, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, D&C Red No. 28, and FD&C Blue No. 1. The 100 mg strength also contains FD&C Blue No. 2, FD&C Red No. 40 and D&C Yellow No. 10."
},
{
"NDCCode": "10370-176-28",
"PackageDescription": "750 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-28) ",
"NDC11Code": "10370-0176-28",
"ProductNDC": "10370-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvoxamine Maleate",
"NonProprietaryName": "Fluvoxamine Maleate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091476",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "FLUVOXAMINE MALEATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130313",
"SamplePackage": "N",
"IndicationAndUsage": "Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (1). Efficacy was demonstrated in: 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults (14.1)., 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (14.1, 14.3)., 3 One maintenance study with IR fluvoxamine tablets (14.2).",
"Description": "Fluvoxamine maleate extended-release capsules are an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as 5-methoxy-4’-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3C4H4O4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, each capsule contains the following inactive ingredients: black iron oxide, dehydrated alcohol, ethylcellulose, gelatin, hydroxypropyl cellulose, isopropyl alcohol, povidone, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, D&C Red No. 28, and FD&C Blue No. 1. The 100 mg strength also contains FD&C Blue No. 2, FD&C Red No. 40 and D&C Yellow No. 10."
},
{
"NDCCode": "10544-176-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (10544-176-30)",
"NDC11Code": "10544-0176-30",
"ProductNDC": "10544-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074253",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4.5]decane-7,9- dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Each tablet for oral administration containing 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "10544-176-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (10544-176-90)",
"NDC11Code": "10544-0176-90",
"ProductNDC": "10544-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074253",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4.5]decane-7,9- dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Each tablet for oral administration containing 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "11489-176-01",
"PackageDescription": "1 TUBE in 1 CARTON (11489-176-01) > 50 g in 1 TUBE",
"NDC11Code": "11489-0176-01",
"ProductNDC": "11489-176",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Laboratories Acne Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "BCM Ltd",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "g/50g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201104",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. Clean the skin thoroughly before applying the product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.",
"Description": "No7. LABORATORIES. CLINICALLY PROVEN. CLINICALLY PROVEN. ACNE TREATMENT. 2% Salicylic Acid. Reduce the appearance of acne & blemishes overnight. Dermatologist approved. 2% SALICYLIC ACID. + PRE-BIOTIC TECHNOLOGY. 50 ml e 1.69 US Fl. Oz. No7 Laboratories Acne Treatment is clinically proven to receal healthier and clearer looking skin. Dermatologist approved this medicated 2% Salicylic Acid treatment visibly reduces the appearance of acne overnight. With pre-biotic technology, feed your skin for a nourished, blanaced and health-looking complexion. - Reduces the apperance of acne, blemishes & breakouts overnight. - Renews skin's surface to clear pores, helping to prevent new blemishes forming. - Excess oil is reduced for shine-free skin. - Restores balance to troubled skin. POWERED BY. 2% SALICYLIC ACID. + PRE-BIOTIC TECHNOLOGY. In 1 week women agreed their skin's appearance had been transformed, and after 4 weeks saw their clearest complexion in years. Fragrance free and suitable for sensitive skin. For best results: In the evening after cleansing skin apply a thin layer of the product to troublesome area. Leav on overnight and rinse away in the morning. Use 2-3 times a week."
},
{
"NDCCode": "11534-176-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (11534-176-01) ",
"NDC11Code": "11534-0176-01",
"ProductNDC": "11534-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205019",
"LabelerName": "SUNRISE PHARMACEUTICAL, INC.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170124",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. The limited usefulness of agents of this class, including phentermine, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α, dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15NHCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsule USP is available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base). a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, lactose monohydrate, magnesium stearate. In addition, the 15 mg capsules contain black iron oxide, FD&C red No. 3, FD&C yellow No. 5, titanium dioxide; and the blue and clear 30 mg capsules contain D&C red No. 28, FD&C blue No. 1. The ingredients in the black imprinting ink are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "11534-176-03",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (11534-176-03) ",
"NDC11Code": "11534-0176-03",
"ProductNDC": "11534-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205019",
"LabelerName": "SUNRISE PHARMACEUTICAL, INC.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170124",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. The limited usefulness of agents of this class, including phentermine, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α, dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15NHCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsule USP is available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base). a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, lactose monohydrate, magnesium stearate. In addition, the 15 mg capsules contain black iron oxide, FD&C red No. 3, FD&C yellow No. 5, titanium dioxide; and the blue and clear 30 mg capsules contain D&C red No. 28, FD&C blue No. 1. The ingredients in the black imprinting ink are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "13630-0176-4",
"PackageDescription": "156 g in 1 CAN (13630-0176-4) ",
"NDC11Code": "13630-0176-04",
"ProductNDC": "13630-0176",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ulta Beauty",
"ProprietaryNameSuffix": "Broad Spectrum Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210311",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Packaging, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 7.5; 5; 5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210311",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. 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."
},
{
"NDCCode": "13734-176-60",
"PackageDescription": "1 TUBE in 1 CARTON (13734-176-60) / 50 mL in 1 TUBE",
"NDC11Code": "13734-0176-60",
"ProductNDC": "13734-176",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nars Pure Radiant Tinted Moisturizer Cuzco",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "NARS Cosmetics",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "3.745; 3.125",
"StrengthUnit": "g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. 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."
},
{
"NDCCode": "16714-176-01",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16714-176-01) ",
"NDC11Code": "16714-0176-01",
"ProductNDC": "16714-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210801",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210801",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "16714-176-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16714-176-02) ",
"NDC11Code": "16714-0176-02",
"ProductNDC": "16714-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210801",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "16714-176-03",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-176-03) ",
"NDC11Code": "16714-0176-03",
"ProductNDC": "16714-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210801",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210801",
"EndMarketingDatePackage": "20271031",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "21695-176-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-176-30)",
"NDC11Code": "21695-0176-30",
"ProductNDC": "21695-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nefazodone Hydrochloride",
"NonProprietaryName": "Nefazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076037",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NEFAZODONE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and 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 efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Nefazodone hydrochloride tablets are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant."
},
{
"NDCCode": "21695-176-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (21695-176-60)",
"NDC11Code": "21695-0176-60",
"ProductNDC": "21695-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nefazodone Hydrochloride",
"NonProprietaryName": "Nefazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076037",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NEFAZODONE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and 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 efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Nefazodone hydrochloride tablets are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant."
},
{
"NDCCode": "25021-176-20",
"PackageDescription": "10 VIAL in 1 CARTON (25021-176-20) / 15 mL in 1 VIAL",
"NDC11Code": "25021-0176-20",
"ProductNDC": "25021-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin Sodium, Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210915",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208674",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/15mL; g/15mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210915",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and Tazobactam for Injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .",
"Description": "Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets the USP Organic Impurities modified Test Procedure 1."
},
{
"NDCCode": "27241-176-13",
"PackageDescription": "112 TABLET in 1 BOTTLE (27241-176-13) ",
"NDC11Code": "27241-0176-13",
"ProductNDC": "27241-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetrabenazine",
"NonProprietaryName": "Tetrabenazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213621",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "TETRABENAZINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201227",
"SamplePackage": "N",
"IndicationAndUsage": "Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease.",
"Description": "Tetrabenazine is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11bhexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is off-white to pale yellow powder that is sparingly soluble in methanol and soluble in chloroform. Each tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose monohydrate, ferric oxide yellow, corn starch, pregelatinized starch, magnesium stearate and talc. The 12.5 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, non-scored tablets debossed with ‘T1’ on one side and plain on other side. The 25 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, functionally scored tablets debossed with ‘T’ on both side of scored line and plain on other side."
},
{
"NDCCode": "29300-176-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (29300-176-01) ",
"NDC11Code": "29300-0176-01",
"ProductNDC": "29300-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203025",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220221",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red)."
},
{
"NDCCode": "29300-176-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (29300-176-05) ",
"NDC11Code": "29300-0176-05",
"ProductNDC": "29300-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203025",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220221",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red)."
},
{
"NDCCode": "29300-176-13",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (29300-176-13) ",
"NDC11Code": "29300-0176-13",
"ProductNDC": "29300-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203025",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220221",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red)."
},
{
"NDCCode": "31722-176-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-176-01) ",
"NDC11Code": "31722-0176-01",
"ProductNDC": "31722-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075903",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210817",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as 1-[N2-[( S)-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, mannitol and pregelatinized starch (maize). In addition 5 mg, 10 mg, 20 mg and 30 mg tablets contain ferric oxide red, and 40 mg tablets contain ferric oxide yellow."
}
]
}
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<NDCList>
<NDC>
<NDCCode>49288-0176-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0176-3)</PackageDescription>
<NDC11Code>49288-0176-03</NDC11Code>
<ProductNDC>49288-0176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920206</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102224</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>3000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>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>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920206</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102224</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>3000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>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>
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<ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920206</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>3000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>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>15631-0176-3</NDCCode>
<PackageDescription>750 PELLET in 1 PACKAGE (15631-0176-3) </PackageDescription>
<NDC11Code>15631-0176-03</NDC11Code>
<ProductNDC>15631-0176</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Epigaea Repens</ProprietaryName>
<NonProprietaryName>Epigaea Repens</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>EPIGAEA REPENS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0176-3</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-0176-3) </PackageDescription>
<NDC11Code>37662-0176-03</NDC11Code>
<ProductNDC>37662-0176</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>12</StrengthNumber>
<StrengthUnit>[hp_C]/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>50090-0176-3</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-0176-3) </PackageDescription>
<NDC11Code>50090-0176-03</NDC11Code>
<ProductNDC>50090-0176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</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>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51552-0176-3</NDCCode>
<PackageDescription>25 g in 1 CONTAINER (51552-0176-3)</PackageDescription>
<NDC11Code>51552-0176-03</NDC11Code>
<ProductNDC>51552-0176</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190226</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70000-0176-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70000-0176-3) > 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>70000-0176-03</NDC11Code>
<ProductNDC>70000-0176</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072096</ApplicationNumber>
<LabelerName>Cardinal Health 110, LLC. dba Leader</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0176-3</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-0176-3) </PackageDescription>
<NDC11Code>71335-0176-03</NDC11Code>
<ProductNDC>71335-0176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>0338-0176-01</NDCCode>
<PackageDescription>30 BAG in 1 CARTON (0338-0176-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-0176-01</NDC11Code>
<ProductNDC>0338-0176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19921207</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020179</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 13 mm or 20 mm closure.</IndicationAndUsage>
<Description>Dextrose Injection, 5% USP is a clear, sterile, non-pyrogenic solution of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)]. Flexible containers, designed to facilitate admixture, are available in 50 mL and 100 mL sizes. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The Mini-Bag Plus Container System is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered or liquid (up to 10 mL) drug vial having a 13mm or 20mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of a powdered or a liquid (up to 10mL) drug. The Mini-Bag Plus product mechanically prohibits the transfer of contaminants into and out of the system during and after docking, minimizing environmental and personal exposure. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an infusion solution for delivery to the patient. The VIAFLEX Plastic Container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>10370-176-11</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-11) </PackageDescription>
<NDC11Code>10370-0176-11</NDC11Code>
<ProductNDC>10370-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
<NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091476</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (1). Efficacy was demonstrated in: 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults (14.1)., 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (14.1, 14.3)., 3 One maintenance study with IR fluvoxamine tablets (14.2).</IndicationAndUsage>
<Description>Fluvoxamine maleate extended-release capsules are an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as 5-methoxy-4’-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3C4H4O4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, each capsule contains the following inactive ingredients: black iron oxide, dehydrated alcohol, ethylcellulose, gelatin, hydroxypropyl cellulose, isopropyl alcohol, povidone, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, D&C Red No. 28, and FD&C Blue No. 1. The 100 mg strength also contains FD&C Blue No. 2, FD&C Red No. 40 and D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>10370-176-28</NDCCode>
<PackageDescription>750 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-28) </PackageDescription>
<NDC11Code>10370-0176-28</NDC11Code>
<ProductNDC>10370-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
<NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091476</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (1). Efficacy was demonstrated in: 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults (14.1)., 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (14.1, 14.3)., 3 One maintenance study with IR fluvoxamine tablets (14.2).</IndicationAndUsage>
<Description>Fluvoxamine maleate extended-release capsules are an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as 5-methoxy-4’-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3C4H4O4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, each capsule contains the following inactive ingredients: black iron oxide, dehydrated alcohol, ethylcellulose, gelatin, hydroxypropyl cellulose, isopropyl alcohol, povidone, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, D&C Red No. 28, and FD&C Blue No. 1. The 100 mg strength also contains FD&C Blue No. 2, FD&C Red No. 40 and D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>10544-176-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (10544-176-30)</PackageDescription>
<NDC11Code>10544-0176-30</NDC11Code>
<ProductNDC>10544-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4.5]decane-7,9- dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Each tablet for oral administration containing 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10544-176-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (10544-176-90)</PackageDescription>
<NDC11Code>10544-0176-90</NDC11Code>
<ProductNDC>10544-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4.5]decane-7,9- dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Each tablet for oral administration containing 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>11489-176-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11489-176-01) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>11489-0176-01</NDC11Code>
<ProductNDC>11489-176</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Laboratories Acne Treatment</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. Clean the skin thoroughly before applying the product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.</IndicationAndUsage>
<Description>No7. LABORATORIES. CLINICALLY PROVEN. CLINICALLY PROVEN. ACNE TREATMENT. 2% Salicylic Acid. Reduce the appearance of acne & blemishes overnight. Dermatologist approved. 2% SALICYLIC ACID. + PRE-BIOTIC TECHNOLOGY. 50 ml e 1.69 US Fl. Oz. No7 Laboratories Acne Treatment is clinically proven to receal healthier and clearer looking skin. Dermatologist approved this medicated 2% Salicylic Acid treatment visibly reduces the appearance of acne overnight. With pre-biotic technology, feed your skin for a nourished, blanaced and health-looking complexion. - Reduces the apperance of acne, blemishes & breakouts overnight. - Renews skin's surface to clear pores, helping to prevent new blemishes forming. - Excess oil is reduced for shine-free skin. - Restores balance to troubled skin. POWERED BY. 2% SALICYLIC ACID. + PRE-BIOTIC TECHNOLOGY. In 1 week women agreed their skin's appearance had been transformed, and after 4 weeks saw their clearest complexion in years. Fragrance free and suitable for sensitive skin. For best results: In the evening after cleansing skin apply a thin layer of the product to troublesome area. Leav on overnight and rinse away in the morning. Use 2-3 times a week.</Description>
</NDC>
<NDC>
<NDCCode>11534-176-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (11534-176-01) </PackageDescription>
<NDC11Code>11534-0176-01</NDC11Code>
<ProductNDC>11534-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205019</ApplicationNumber>
<LabelerName>SUNRISE PHARMACEUTICAL, INC.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. The limited usefulness of agents of this class, including phentermine, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α, dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15NHCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsule USP is available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base). a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, lactose monohydrate, magnesium stearate. In addition, the 15 mg capsules contain black iron oxide, FD&C red No. 3, FD&C yellow No. 5, titanium dioxide; and the blue and clear 30 mg capsules contain D&C red No. 28, FD&C blue No. 1. The ingredients in the black imprinting ink are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>11534-176-03</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (11534-176-03) </PackageDescription>
<NDC11Code>11534-0176-03</NDC11Code>
<ProductNDC>11534-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205019</ApplicationNumber>
<LabelerName>SUNRISE PHARMACEUTICAL, INC.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. The limited usefulness of agents of this class, including phentermine, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α, dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15NHCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsule USP is available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base). a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, lactose monohydrate, magnesium stearate. In addition, the 15 mg capsules contain black iron oxide, FD&C red No. 3, FD&C yellow No. 5, titanium dioxide; and the blue and clear 30 mg capsules contain D&C red No. 28, FD&C blue No. 1. The ingredients in the black imprinting ink are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>13630-0176-4</NDCCode>
<PackageDescription>156 g in 1 CAN (13630-0176-4) </PackageDescription>
<NDC11Code>13630-0176-04</NDC11Code>
<ProductNDC>13630-0176</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ulta Beauty</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210311</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 7.5; 5; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. 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>13734-176-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (13734-176-60) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>13734-0176-60</NDC11Code>
<ProductNDC>13734-176</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nars Pure Radiant Tinted Moisturizer Cuzco</ProprietaryName>
<NonProprietaryName>Octinoxate And 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>3.745; 3.125</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. 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>16714-176-01</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16714-176-01) </PackageDescription>
<NDC11Code>16714-0176-01</NDC11Code>
<ProductNDC>16714-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210801</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210801</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16714-176-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16714-176-02) </PackageDescription>
<NDC11Code>16714-0176-02</NDC11Code>
<ProductNDC>16714-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16714-176-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16714-176-03) </PackageDescription>
<NDC11Code>16714-0176-03</NDC11Code>
<ProductNDC>16714-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210801</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210801</StartMarketingDatePackage>
<EndMarketingDatePackage>20271031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-176-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-176-30)</PackageDescription>
<NDC11Code>21695-0176-30</NDC11Code>
<ProductNDC>21695-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nefazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Nefazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076037</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NEFAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and 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 efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Nefazodone hydrochloride tablets are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>21695-176-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (21695-176-60)</PackageDescription>
<NDC11Code>21695-0176-60</NDC11Code>
<ProductNDC>21695-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nefazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Nefazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076037</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NEFAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and 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 efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Nefazodone hydrochloride tablets are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>25021-176-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-176-20) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0176-20</NDC11Code>
<ProductNDC>25021-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium, Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210915</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208674</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>3; .375</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210915</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and Tazobactam for Injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .</IndicationAndUsage>
<Description>Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets the USP Organic Impurities modified Test Procedure 1.</Description>
</NDC>
<NDC>
<NDCCode>27241-176-13</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (27241-176-13) </PackageDescription>
<NDC11Code>27241-0176-13</NDC11Code>
<ProductNDC>27241-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetrabenazine</ProprietaryName>
<NonProprietaryName>Tetrabenazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213621</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>TETRABENAZINE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease.</IndicationAndUsage>
<Description>Tetrabenazine is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11bhexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula C19H27NO3 is represented by the following structural formula. Tetrabenazine is off-white to pale yellow powder that is sparingly soluble in methanol and soluble in chloroform. Each tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient. Tetrabenazine tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose monohydrate, ferric oxide yellow, corn starch, pregelatinized starch, magnesium stearate and talc. The 12.5 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, non-scored tablets debossed with ‘T1’ on one side and plain on other side. The 25 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, functionally scored tablets debossed with ‘T’ on both side of scored line and plain on other side.</Description>
</NDC>
<NDC>
<NDCCode>29300-176-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (29300-176-01) </PackageDescription>
<NDC11Code>29300-0176-01</NDC11Code>
<ProductNDC>29300-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203025</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red).</Description>
</NDC>
<NDC>
<NDCCode>29300-176-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (29300-176-05) </PackageDescription>
<NDC11Code>29300-0176-05</NDC11Code>
<ProductNDC>29300-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203025</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red).</Description>
</NDC>
<NDC>
<NDCCode>29300-176-13</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (29300-176-13) </PackageDescription>
<NDC11Code>29300-0176-13</NDC11Code>
<ProductNDC>29300-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203025</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: : 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets, Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1 piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, corn starch, magnesium stearate, and microcrystalline cellulose. Additionally, 10 mg, 15 mg, 20 mg, and 30 mg include colorant ferric oxide (red).</Description>
</NDC>
<NDC>
<NDCCode>31722-176-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-176-01) </PackageDescription>
<NDC11Code>31722-0176-01</NDC11Code>
<ProductNDC>31722-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075903</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as 1-[N2-[( S)-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, mannitol and pregelatinized starch (maize). In addition 5 mg, 10 mg, 20 mg and 30 mg tablets contain ferric oxide red, and 40 mg tablets contain ferric oxide yellow.</Description>
</NDC>
</NDCList>