{
"NDC": [
{
"NDCCode": "52125-844-57",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (52125-844-57)",
"NDC11Code": "52125-0844-57",
"ProductNDC": "52125-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "52125-844-14",
"PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE (52125-844-14)",
"NDC11Code": "52125-0844-14",
"ProductNDC": "52125-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "52125-844-38",
"PackageDescription": "3 TABLET, FILM COATED in 1 CARTON (52125-844-38)",
"NDC11Code": "52125-0844-38",
"ProductNDC": "52125-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "52125-232-57",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (52125-232-57)",
"NDC11Code": "52125-0232-57",
"ProductNDC": "52125-232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20130926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064096",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "52125-283-57",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (52125-283-57)",
"NDC11Code": "52125-0283-57",
"ProductNDC": "52125-283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076231",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-20"
},
{
"NDCCode": "52125-332-57",
"PackageDescription": "5 TABLET in 1 BOTTLE (52125-332-57)",
"NDC11Code": "52125-0332-57",
"ProductNDC": "52125-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077829",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "52125-413-57",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (52125-413-57)",
"NDC11Code": "52125-0413-57",
"ProductNDC": "52125-413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076128",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "52125-461-57",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (52125-461-57)",
"NDC11Code": "52125-0461-57",
"ProductNDC": "52125-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20141119",
"EndMarketingDate": "20170318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062452",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "52125-475-57",
"PackageDescription": "5 mL in 1 BOTTLE, DISPENSING (52125-475-57)",
"NDC11Code": "52125-0475-57",
"ProductNDC": "52125-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020330",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "6.8",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-02-17"
},
{
"NDCCode": "52125-489-57",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (52125-489-57)",
"NDC11Code": "52125-0489-57",
"ProductNDC": "52125-489",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078559",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "52125-525-57",
"PackageDescription": "5 TABLET, FILM COATED in 1 VIAL (52125-525-57)",
"NDC11Code": "52125-0525-57",
"ProductNDC": "52125-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avelox",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130708",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021085",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "52125-527-57",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (52125-527-57)",
"NDC11Code": "52125-0527-57",
"ProductNDC": "52125-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150820",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "52125-537-57",
"PackageDescription": "5 mL in 1 BOTTLE (52125-537-57)",
"NDC11Code": "52125-0537-57",
"ProductNDC": "52125-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141017",
"EndMarketingDate": "20170825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077689",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "52125-600-57",
"PackageDescription": "5 TABLET in 1 BOTTLE (52125-600-57)",
"NDC11Code": "52125-0600-57",
"ProductNDC": "52125-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadineantihistamine",
"ProprietaryNameSuffix": "Antihistamine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "52125-656-57",
"PackageDescription": "5 mL in 1 BOTTLE (52125-656-57)",
"NDC11Code": "52125-0656-57",
"ProductNDC": "52125-656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078222",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "52125-787-57",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (52125-787-57)",
"NDC11Code": "52125-0787-57",
"ProductNDC": "52125-787",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065509",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-27"
},
{
"NDCCode": "52125-804-57",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (52125-804-57)",
"NDC11Code": "52125-0804-57",
"ProductNDC": "52125-804",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076622",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-02-17"
},
{
"NDCCode": "52125-836-57",
"PackageDescription": ".5 mL in 1 VIAL, SINGLE-DOSE (52125-836-57)",
"NDC11Code": "52125-0836-57",
"ProductNDC": "52125-836",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Menactra",
"NonProprietaryName": "Neisseria Meningitidis Group A Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20150103",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125089",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN",
"StrengthNumber": "4; 4; 4; 4",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "52125-848-57",
"PackageDescription": "5 mL in 1 CONTAINER (52125-848-57)",
"NDC11Code": "52125-0848-57",
"ProductNDC": "52125-848",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Adacel Tdap",
"ProprietaryNameSuffix": "Tdap",
"NonProprietaryName": "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20151019",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125111",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "5; 5; 3; 2.5; 5; 2",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL",
"Pharm_Classes": "Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-03-25"
},
{
"NDCCode": "52125-849-57",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (52125-849-57)",
"NDC11Code": "52125-0849-57",
"ProductNDC": "52125-849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140804",
"EndMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076407",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "52125-947-57",
"PackageDescription": "1.5 g in 1 TUBE (52125-947-57)",
"NDC11Code": "52125-0947-57",
"ProductNDC": "52125-947",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Denavir",
"NonProprietaryName": "Penciclovir",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140527",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020629",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PENCICLOVIR",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-20"
},
{
"NDCCode": "64380-844-04",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (64380-844-04) ",
"NDC11Code": "64380-0844-04",
"ProductNDC": "64380-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursodiol",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210344",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "URSODIOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210913",
"SamplePackage": "N",
"IndicationAndUsage": "Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.",
"Description": "Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, iron oxide red, titanium dioxide, gelatin. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide."
},
{
"NDCCode": "64380-844-06",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (64380-844-06) ",
"NDC11Code": "64380-0844-06",
"ProductNDC": "64380-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursodiol",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210344",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "URSODIOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210913",
"SamplePackage": "N",
"IndicationAndUsage": "Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.",
"Description": "Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, iron oxide red, titanium dioxide, gelatin. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide."
},
{
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"PackageDescription": "500 CAPSULE in 1 BOTTLE (64380-844-07) ",
"NDC11Code": "64380-0844-07",
"ProductNDC": "64380-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursodiol",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210344",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "URSODIOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210913",
"SamplePackage": "N",
"IndicationAndUsage": "Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.",
"Description": "Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, iron oxide red, titanium dioxide, gelatin. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide."
},
{
"NDCCode": "0378-4513-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4513-93) ",
"NDC11Code": "00378-4513-93",
"ProductNDC": "0378-4513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Atorvastatin",
"NonProprietaryName": "Amlodipine And Atorvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200465",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150402",
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"IndicationAndUsage": "Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
},
{
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"ProductNDC": "0378-4514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Atorvastatin",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200465",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
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"IndicationAndUsage": "Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
},
{
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"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
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"IndicationAndUsage": "Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium."
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<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20131125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076128</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-461-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (52125-461-57)</PackageDescription>
<NDC11Code>52125-0461-57</NDC11Code>
<ProductNDC>52125-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20141119</StartMarketingDate>
<EndMarketingDate>20170318</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062452</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-475-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DISPENSING (52125-475-57)</PackageDescription>
<NDC11Code>52125-0475-57</NDC11Code>
<ProductNDC>52125-475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20131203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020330</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>6.8</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-489-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, PLASTIC (52125-489-57)</PackageDescription>
<NDC11Code>52125-0489-57</NDC11Code>
<ProductNDC>52125-489</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20131125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078559</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-525-57</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 VIAL (52125-525-57)</PackageDescription>
<NDC11Code>52125-0525-57</NDC11Code>
<ProductNDC>52125-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avelox</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130708</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021085</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-527-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (52125-527-57)</PackageDescription>
<NDC11Code>52125-0527-57</NDC11Code>
<ProductNDC>52125-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150820</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-537-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (52125-537-57)</PackageDescription>
<NDC11Code>52125-0537-57</NDC11Code>
<ProductNDC>52125-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141017</StartMarketingDate>
<EndMarketingDate>20170825</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077689</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-600-57</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (52125-600-57)</PackageDescription>
<NDC11Code>52125-0600-57</NDC11Code>
<ProductNDC>52125-600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadineantihistamine</ProprietaryName>
<ProprietaryNameSuffix>Antihistamine</ProprietaryNameSuffix>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-656-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (52125-656-57)</PackageDescription>
<NDC11Code>52125-0656-57</NDC11Code>
<ProductNDC>52125-656</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20131125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078222</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-787-57</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (52125-787-57)</PackageDescription>
<NDC11Code>52125-0787-57</NDC11Code>
<ProductNDC>52125-787</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065509</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-804-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (52125-804-57)</PackageDescription>
<NDC11Code>52125-0804-57</NDC11Code>
<ProductNDC>52125-804</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20140514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076622</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-836-57</NDCCode>
<PackageDescription>.5 mL in 1 VIAL, SINGLE-DOSE (52125-836-57)</PackageDescription>
<NDC11Code>52125-0836-57</NDC11Code>
<ProductNDC>52125-836</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Menactra</ProprietaryName>
<NonProprietaryName>Neisseria Meningitidis Group A Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20150103</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125089</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN</SubstanceName>
<StrengthNumber>4; 4; 4; 4</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-848-57</NDCCode>
<PackageDescription>5 mL in 1 CONTAINER (52125-848-57)</PackageDescription>
<NDC11Code>52125-0848-57</NDC11Code>
<ProductNDC>52125-848</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Adacel Tdap</ProprietaryName>
<ProprietaryNameSuffix>Tdap</ProprietaryNameSuffix>
<NonProprietaryName>Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20151019</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125111</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>5; 5; 3; 2.5; 5; 2</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL</StrengthUnit>
<Pharm_Classes>Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-03-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-849-57</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (52125-849-57)</PackageDescription>
<NDC11Code>52125-0849-57</NDC11Code>
<ProductNDC>52125-849</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20140804</StartMarketingDate>
<EndMarketingDate>20171117</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076407</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-947-57</NDCCode>
<PackageDescription>1.5 g in 1 TUBE (52125-947-57)</PackageDescription>
<NDC11Code>52125-0947-57</NDC11Code>
<ProductNDC>52125-947</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Denavir</ProprietaryName>
<NonProprietaryName>Penciclovir</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140527</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020629</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PENCICLOVIR</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-20</LastUpdate>
</NDC>
<NDC>
<NDCCode>64380-844-04</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (64380-844-04) </PackageDescription>
<NDC11Code>64380-0844-04</NDC11Code>
<ProductNDC>64380-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursodiol</ProprietaryName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210344</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.</IndicationAndUsage>
<Description>Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, iron oxide red, titanium dioxide, gelatin. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>64380-844-06</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (64380-844-06) </PackageDescription>
<NDC11Code>64380-0844-06</NDC11Code>
<ProductNDC>64380-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursodiol</ProprietaryName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210344</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.</IndicationAndUsage>
<Description>Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, iron oxide red, titanium dioxide, gelatin. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>64380-844-07</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (64380-844-07) </PackageDescription>
<NDC11Code>64380-0844-07</NDC11Code>
<ProductNDC>64380-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursodiol</ProprietaryName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210344</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
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<IndicationAndUsage>Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.</IndicationAndUsage>
<Description>Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder freely soluble in alcohol; slightly soluble in acetone and in methylene chloride; very slightly soluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Corn starch, colloidal silicon dioxide, magnesium stearate, talc, iron oxide red, titanium dioxide, gelatin. The imprinting ink contains shellac, black iron oxide and traces of potassium hydroxide.</Description>
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<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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