{
"NDC": [
{
"NDCCode": "52959-534-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (52959-534-30)",
"NDC11Code": "52959-0534-30",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (52959-534-00)",
"NDC11Code": "52959-0534-00",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-01",
"PackageDescription": "120 TABLET in 1 BOTTLE (52959-534-01)",
"NDC11Code": "52959-0534-01",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-02",
"PackageDescription": "2 TABLET in 1 BOTTLE (52959-534-02)",
"NDC11Code": "52959-0534-02",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (52959-534-10)",
"NDC11Code": "52959-0534-10",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (52959-534-12)",
"NDC11Code": "52959-0534-12",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (52959-534-15)",
"NDC11Code": "52959-0534-15",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (52959-534-20)",
"NDC11Code": "52959-0534-20",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-24",
"PackageDescription": "24 TABLET in 1 BOTTLE (52959-534-24)",
"NDC11Code": "52959-0534-24",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (52959-534-28)",
"NDC11Code": "52959-0534-28",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (52959-534-45)",
"NDC11Code": "52959-0534-45",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (52959-534-60)",
"NDC11Code": "52959-0534-60",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "52959-534-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (52959-534-90)",
"NDC11Code": "52959-0534-90",
"ProductNDC": "52959-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "10544-534-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-534-30)",
"NDC11Code": "10544-0534-30",
"ProductNDC": "10544-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071523",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)].",
"Description": "Trazodone hydrochloride is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water. Chemical Name: 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride. Structural Formula:. Each tablet, for oral administration, contains 50 mg, 100 mg and 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "13668-534-02",
"PackageDescription": "30 g in 1 TUBE (13668-534-02) ",
"NDC11Code": "13668-0534-02",
"ProductNDC": "13668-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211838",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "U/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190129",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula. Nystatin ointment is for dermatologic use. Nystatin ointment for topical use contains 100,000 USP nystatin units per gram in an ointment base of light mineral oil and white petrolatum."
},
{
"NDCCode": "16252-534-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16252-534-30)",
"NDC11Code": "16252-0534-30",
"ProductNDC": "16252-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077663",
"LabelerName": "Cobalt Laboratories Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "16714-534-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-534-01) ",
"NDC11Code": "16714-0534-01",
"ProductNDC": "16714-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203442",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "200; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2022-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220309",
"SamplePackage": "N",
"IndicationAndUsage": "HIV-1 Treatment (1.1) Emtricitabine and Tenofovir Disoproxil Fumarate Tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP (1.2): Emtricitabine and Tenofovir Disoproxil Fumarate is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP.",
"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2R,5S)-[2- (hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula. FTC is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 °C. The partition coefficient (log p) for emtricitabine is ―0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P. C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strengths. Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets also include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and pregelatinized starch. The tablets are coated with Instacoat Universal White A05G14934, which contains hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin."
},
{
"NDCCode": "21695-534-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-534-30)",
"NDC11Code": "21695-0534-30",
"ProductNDC": "21695-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078296",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lovastatin tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin tablets are indicated to reduce the risk of. - Myocardial infarction. - Unstable angina. - Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Coronary Heart Disease. Lovastatin tablets are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb***), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present: 1 LDL-C remains >189 mg/dL or , 2 LDL-C remains >160 mg/dL and:.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutarylcoenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*), 8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "31722-534-30",
"PackageDescription": "12 BOTTLE in 1 CASE (31722-534-30) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "31722-0534-30",
"ProductNDC": "31722-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130320",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid."
},
{
"NDCCode": "33261-534-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-534-30)",
"NDC11Code": "33261-0534-30",
"ProductNDC": "33261-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040159",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Medroxyprogesterone Acetate Tablets USP are a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone Acetate Tablets USP are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.",
"Description": "Medroxyprogesterone Acetate Tablets USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized starch, and sodium lauryl sulfate."
},
{
"NDCCode": "33342-534-07",
"PackageDescription": "30 TABLET in 1 BOTTLE (33342-534-07) ",
"NDC11Code": "33342-0534-07",
"ProductNDC": "33342-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218335",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DAPSONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260708",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Microcrystalline cellulose, corn starch, Colloidal silicone dioxide, sodium lauryl sulphate and magnesium stearate."
},
{
"NDCCode": "42549-534-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42549-534-30)",
"NDC11Code": "42549-0534-30",
"ProductNDC": "42549-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077856",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Clonazepam Tablets USP, a benzodiazepine, is available as scored tablets containing 0.5 mg of clonazepam and unscored tablets containing 1 mg or 2 mg of clonazepam. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "43744-534-30",
"PackageDescription": "50 g in 1 DRUM (43744-534-30)",
"NDC11Code": "43744-0534-30",
"ProductNDC": "43744-534",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Latanoprost",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110808",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "LATANOPROST",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "49884-534-11",
"PackageDescription": "30 TABLET in 1 BOTTLE (49884-534-11) ",
"NDC11Code": "49884-0534-11",
"ProductNDC": "49884-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Modafinil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120406",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020717",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120406",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "51655-534-52",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-534-52) ",
"NDC11Code": "51655-0534-52",
"ProductNDC": "51655-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220519",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "52125-534-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-534-02)",
"NDC11Code": "52125-0534-02",
"ProductNDC": "52125-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090637",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "52187-534-01",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (52187-534-01) > 30 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "52187-0534-01",
"ProductNDC": "52187-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate 2.5% Pramoxine Hcl 1%",
"NonProprietaryName": "Hydrocortisone Acetate, Pramoxine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "KMM Pharmaceuticals, LLC",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "N"
},
{
"NDCCode": "53943-534-30",
"PackageDescription": "245 mL in 1 BOTTLE (53943-534-30) ",
"NDC11Code": "53943-0534-30",
"ProductNDC": "53943-534",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Severe Cold And Cough Relief",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160804",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Discount Drug Mart",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 12.5; 5",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160804",
"SamplePackage": "N"
},
{
"NDCCode": "54860-534-01",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (54860-534-01) ",
"NDC11Code": "54860-0534-01",
"ProductNDC": "54860-534",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Hand Sanitizer Spider-man",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251111",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251111",
"SamplePackage": "Y",
"IndicationAndUsage": "Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product."
},
{
"NDCCode": "55111-534-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-534-30) ",
"NDC11Code": "55111-0534-30",
"ProductNDC": "55111-534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090070",
"LabelerName": "Dr. Reddy's Laboratories Ltd",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130811",
"SamplePackage": "N",
"Description": "Divalproex sodium USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium USP has the following structure:. Divalproex sodium USP occurs as a white to off white powder with a characteristic odor, very soluble in chloroform, freely soluble in methanol and ethyl ether, soluble in acetone, practically insoluble in acetonitrile. Divalproex sodium extended-release tablets USP, 500 mg are for oral administration. Divalproex sodium extended-release tablets USP, contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release tablets USP, 500mg: Hydroxy ethyl cellulose, hydroxy propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, silicon dioxide, and titanium dioxide. Divalproex sodium extended-release tablets meets USP Dissolution Test 5."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52959-534-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52959-534-30)</PackageDescription>
<NDC11Code>52959-0534-30</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (52959-534-00)</PackageDescription>
<NDC11Code>52959-0534-00</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-01</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (52959-534-01)</PackageDescription>
<NDC11Code>52959-0534-01</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-02</NDCCode>
<PackageDescription>2 TABLET in 1 BOTTLE (52959-534-02)</PackageDescription>
<NDC11Code>52959-0534-02</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (52959-534-10)</PackageDescription>
<NDC11Code>52959-0534-10</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (52959-534-12)</PackageDescription>
<NDC11Code>52959-0534-12</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (52959-534-15)</PackageDescription>
<NDC11Code>52959-0534-15</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (52959-534-20)</PackageDescription>
<NDC11Code>52959-0534-20</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-24</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (52959-534-24)</PackageDescription>
<NDC11Code>52959-0534-24</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (52959-534-28)</PackageDescription>
<NDC11Code>52959-0534-28</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE (52959-534-45)</PackageDescription>
<NDC11Code>52959-0534-45</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (52959-534-60)</PackageDescription>
<NDC11Code>52959-0534-60</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>52959-534-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (52959-534-90)</PackageDescription>
<NDC11Code>52959-0534-90</NDC11Code>
<ProductNDC>52959-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>10544-534-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-534-30)</PackageDescription>
<NDC11Code>10544-0534-30</NDC11Code>
<ProductNDC>10544-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071523</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</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>Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Trazodone hydrochloride is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water. Chemical Name: 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride. Structural Formula:. Each tablet, for oral administration, contains 50 mg, 100 mg and 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>13668-534-02</NDCCode>
<PackageDescription>30 g in 1 TUBE (13668-534-02) </PackageDescription>
<NDC11Code>13668-0534-02</NDC11Code>
<ProductNDC>13668-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211838</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>U/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula. Nystatin ointment is for dermatologic use. Nystatin ointment for topical use contains 100,000 USP nystatin units per gram in an ointment base of light mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>16252-534-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16252-534-30)</PackageDescription>
<NDC11Code>16252-0534-30</NDC11Code>
<ProductNDC>16252-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077663</ApplicationNumber>
<LabelerName>Cobalt Laboratories Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>16714-534-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-534-01) </PackageDescription>
<NDC11Code>16714-0534-01</NDC11Code>
<ProductNDC>16714-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203442</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>200; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIV-1 Treatment (1.1) Emtricitabine and Tenofovir Disoproxil Fumarate Tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP (1.2): Emtricitabine and Tenofovir Disoproxil Fumarate is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP.</IndicationAndUsage>
<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2R,5S)-[2- (hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula. FTC is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 °C. The partition coefficient (log p) for emtricitabine is ―0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P. C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strengths. Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets also include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and pregelatinized starch. The tablets are coated with Instacoat Universal White A05G14934, which contains hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>21695-534-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-534-30)</PackageDescription>
<NDC11Code>21695-0534-30</NDC11Code>
<ProductNDC>21695-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078296</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lovastatin tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin tablets are indicated to reduce the risk of. - Myocardial infarction. - Unstable angina. - Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Coronary Heart Disease. Lovastatin tablets are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb***), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present: 1 LDL-C remains >189 mg/dL or , 2 LDL-C remains >160 mg/dL and:.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutarylcoenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*), 8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>31722-534-30</NDCCode>
<PackageDescription>12 BOTTLE in 1 CASE (31722-534-30) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0534-30</NDC11Code>
<ProductNDC>31722-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>33261-534-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-534-30)</PackageDescription>
<NDC11Code>33261-0534-30</NDC11Code>
<ProductNDC>33261-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040159</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Medroxyprogesterone Acetate Tablets USP are a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone Acetate Tablets USP are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
<Description>Medroxyprogesterone Acetate Tablets USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>33342-534-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33342-534-07) </PackageDescription>
<NDC11Code>33342-0534-07</NDC11Code>
<ProductNDC>33342-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218335</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Microcrystalline cellulose, corn starch, Colloidal silicone dioxide, sodium lauryl sulphate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>42549-534-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42549-534-30)</PackageDescription>
<NDC11Code>42549-0534-30</NDC11Code>
<ProductNDC>42549-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077856</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Clonazepam Tablets USP, a benzodiazepine, is available as scored tablets containing 0.5 mg of clonazepam and unscored tablets containing 1 mg or 2 mg of clonazepam. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>43744-534-30</NDCCode>
<PackageDescription>50 g in 1 DRUM (43744-534-30)</PackageDescription>
<NDC11Code>43744-0534-30</NDC11Code>
<ProductNDC>43744-534</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Latanoprost</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110808</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>LATANOPROST</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-534-11</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (49884-534-11) </PackageDescription>
<NDC11Code>49884-0534-11</NDC11Code>
<ProductNDC>49884-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Modafinil</ProprietaryName>
<NonProprietaryName>Modafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120406</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020717</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120406</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51655-534-52</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-534-52) </PackageDescription>
<NDC11Code>51655-0534-52</NDC11Code>
<ProductNDC>51655-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>52125-534-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-534-02)</PackageDescription>
<NDC11Code>52125-0534-02</NDC11Code>
<ProductNDC>52125-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090637</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>52187-534-01</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (52187-534-01) > 30 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>52187-0534-01</NDC11Code>
<ProductNDC>52187-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate 2.5% Pramoxine Hcl 1%</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate, Pramoxine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>KMM Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53943-534-30</NDCCode>
<PackageDescription>245 mL in 1 BOTTLE (53943-534-30) </PackageDescription>
<NDC11Code>53943-0534-30</NDC11Code>
<ProductNDC>53943-534</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Severe Cold And Cough Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160804</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Discount Drug Mart</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 12.5; 5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54860-534-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (54860-534-01) </PackageDescription>
<NDC11Code>54860-0534-01</NDC11Code>
<ProductNDC>54860-534</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Hand Sanitizer Spider-man</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251111</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-534-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-534-30) </PackageDescription>
<NDC11Code>55111-0534-30</NDC11Code>
<ProductNDC>55111-534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090070</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Ltd</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Divalproex sodium USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium USP has the following structure:. Divalproex sodium USP occurs as a white to off white powder with a characteristic odor, very soluble in chloroform, freely soluble in methanol and ethyl ether, soluble in acetone, practically insoluble in acetonitrile. Divalproex sodium extended-release tablets USP, 500 mg are for oral administration. Divalproex sodium extended-release tablets USP, contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release tablets USP, 500mg: Hydroxy ethyl cellulose, hydroxy propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, silicon dioxide, and titanium dioxide. Divalproex sodium extended-release tablets meets USP Dissolution Test 5.</Description>
</NDC>
</NDCList>