{
"NDC": [
{
"NDCCode": "68428-468-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-468-11) ",
"NDC11Code": "68428-0468-11",
"ProductNDC": "68428-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lapis Albus",
"NonProprietaryName": "Calcium Hexafluorosilicate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N"
},
{
"NDCCode": "68428-468-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-468-03) ",
"NDC11Code": "68428-0468-03",
"ProductNDC": "68428-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lapis Albus",
"NonProprietaryName": "Calcium Hexafluorosilicate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N"
},
{
"NDCCode": "68428-468-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-468-05) ",
"NDC11Code": "68428-0468-05",
"ProductNDC": "68428-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lapis Albus",
"NonProprietaryName": "Calcium Hexafluorosilicate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N"
},
{
"NDCCode": "68428-468-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-468-06) ",
"NDC11Code": "68428-0468-06",
"ProductNDC": "68428-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lapis Albus",
"NonProprietaryName": "Calcium Hexafluorosilicate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N"
},
{
"NDCCode": "68428-468-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-468-12) ",
"NDC11Code": "68428-0468-12",
"ProductNDC": "68428-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lapis Albus",
"NonProprietaryName": "Calcium Hexafluorosilicate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N"
},
{
"NDCCode": "43744-468-11",
"PackageDescription": "5 g in 1 DRUM (43744-468-11)",
"NDC11Code": "43744-0468-11",
"ProductNDC": "43744-468",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Hyaluronate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120707",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "HYALURONATE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "49884-468-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-468-11) ",
"NDC11Code": "49884-0468-11",
"ProductNDC": "49884-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209419",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171116",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine tablets are indicated for the treatment of: 1 Major Depressive Disorder (MDD). The efficacy of fluoxetine tablets in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine tablets was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)]., 2 Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine tablets in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)]., 3 Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine tablets in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies (14.3)]., 4 Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine tablets in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies (14.4)].",
"Description": "Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white or almost white powder, very soluble in ethanol and in chloroform, slightly soluble in acetone and practically insoluble in toluene. Each scored tablet contains fluoxetine hydrochloride, USP equivalent to 60 mg (194 µmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "50268-468-11",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (50268-468-11)",
"NDC11Code": "50268-0468-11",
"ProductNDC": "50268-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077319",
"LabelerName": "AvPAK",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "50268-468-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-468-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-468-11)",
"NDC11Code": "50268-0468-15",
"ProductNDC": "50268-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077319",
"LabelerName": "AvPAK",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-02-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "60687-468-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-468-01) / 1 TABLET in 1 BLISTER PACK (60687-468-11) ",
"NDC11Code": "60687-0468-01",
"ProductNDC": "60687-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "American Health Packaging",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200325",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen, USP is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "68084-468-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-468-01) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (68084-468-11)",
"NDC11Code": "68084-0468-01",
"ProductNDC": "68084-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100915",
"EndMarketingDate": "20160731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "American Health Packaging",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "77267-002-11",
"PackageDescription": "468 mL in 1 PAIL (77267-002-11) ",
"NDC11Code": "77267-0002-11",
"ProductNDC": "77267-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200510",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ningbo�Riway�Industrial�Co.,�Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".75",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on skin."
},
{
"NDCCode": "10237-468-22",
"PackageDescription": "2 BOTTLE in 1 PACKAGE (10237-468-22) / 25 BAR, CHEWABLE in 1 BOTTLE",
"NDC11Code": "10237-0468-22",
"ProductNDC": "10237-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zicam Cold Remedy Medicated Fruit Drops - Assorted Fruit",
"NonProprietaryName": "Zinc Acetate Anhydrous And Zinc Gluconate",
"DosageFormName": "BAR, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20211012",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ZINC ACETATE ANHYDROUS; ZINC GLUCONATE",
"StrengthNumber": "2; 2",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces duration of the common cold and helps relieve nasal congestion. Zicam® Cold Remedy was not formulated to be effective for flu or allergies."
},
{
"NDCCode": "10237-468-25",
"PackageDescription": "25 BAR, CHEWABLE in 1 BOTTLE (10237-468-25) ",
"NDC11Code": "10237-0468-25",
"ProductNDC": "10237-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zicam Cold Remedy Medicated Fruit Drops - Assorted Fruit",
"NonProprietaryName": "Zinc Acetate Anhydrous And Zinc Gluconate",
"DosageFormName": "BAR, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20211012",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ZINC ACETATE ANHYDROUS; ZINC GLUCONATE",
"StrengthNumber": "2; 2",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211012",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces duration of the common cold and helps relieve nasal congestion. Zicam® Cold Remedy was not formulated to be effective for flu or allergies."
},
{
"NDCCode": "36800-468-82",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (36800-468-82) ",
"NDC11Code": "36800-0468-82",
"ProductNDC": "36800-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Antacid Calcium",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20181215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181215",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "37808-468-80",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (37808-468-80)",
"NDC11Code": "37808-0468-80",
"ProductNDC": "37808-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "H E B",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "42829-468-02",
"PackageDescription": "1 TUBE in 1 CARTON (42829-468-02) / 7 g in 1 TUBE",
"NDC11Code": "42829-0468-02",
"ProductNDC": "42829-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zilactin",
"ProprietaryNameSuffix": "Early Relief Cold Sore",
"NonProprietaryName": "Benzyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC",
"SubstanceName": "BENZYL ALCOHOL",
"StrengthNumber": ".1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251106",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves pain caused by: 1 cold sores/fever blisters, 2 canker sores, mouth sores, 3 gum irritations."
},
{
"NDCCode": "43598-313-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-313-05) ",
"NDC11Code": "43598-0313-05",
"ProductNDC": "43598-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-313-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-313-30) ",
"NDC11Code": "43598-0313-30",
"ProductNDC": "43598-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-313-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-313-60) ",
"NDC11Code": "43598-0313-60",
"ProductNDC": "43598-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-313-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43598-313-90) ",
"NDC11Code": "43598-0313-90",
"ProductNDC": "43598-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-314-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-314-05) ",
"NDC11Code": "43598-0314-05",
"ProductNDC": "43598-314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-314-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-314-30) ",
"NDC11Code": "43598-0314-30",
"ProductNDC": "43598-314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-314-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-314-60) ",
"NDC11Code": "43598-0314-60",
"ProductNDC": "43598-314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-314-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43598-314-90) ",
"NDC11Code": "43598-0314-90",
"ProductNDC": "43598-314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-315-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-315-05) ",
"NDC11Code": "43598-0315-05",
"ProductNDC": "43598-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-315-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-315-30) ",
"NDC11Code": "43598-0315-30",
"ProductNDC": "43598-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-315-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-315-60) ",
"NDC11Code": "43598-0315-60",
"ProductNDC": "43598-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-315-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43598-315-90) ",
"NDC11Code": "43598-0315-90",
"ProductNDC": "43598-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43598-316-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-316-05) ",
"NDC11Code": "43598-0316-05",
"ProductNDC": "43598-316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
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"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
}
]
}
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<StrengthUnit>g/g</StrengthUnit>
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<NDC>
<NDCCode>49884-468-11</NDCCode>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077319</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
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<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC11Code>60687-0468-01</NDC11Code>
<ProductNDC>60687-468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen, USP is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
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<NDC11Code>68084-0468-01</NDC11Code>
<ProductNDC>68084-468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
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<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
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<ProprietaryName>Alcohol Wipes</ProprietaryName>
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<DosageFormName>CLOTH</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Ningbo�Riway�Industrial�Co.,�Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-29</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on skin.</IndicationAndUsage>
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<NDC11Code>10237-0468-22</NDC11Code>
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<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>10237-468-25</NDCCode>
<PackageDescription>25 BAR, CHEWABLE in 1 BOTTLE (10237-468-25) </PackageDescription>
<NDC11Code>10237-0468-25</NDC11Code>
<ProductNDC>10237-468</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zicam Cold Remedy Medicated Fruit Drops - Assorted Fruit</ProprietaryName>
<NonProprietaryName>Zinc Acetate Anhydrous And Zinc Gluconate</NonProprietaryName>
<DosageFormName>BAR, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211012</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ZINC ACETATE ANHYDROUS; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2; 2</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces duration of the common cold and helps relieve nasal congestion. Zicam® Cold Remedy was not formulated to be effective for flu or allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-468-82</NDCCode>
<PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (36800-468-82) </PackageDescription>
<NDC11Code>36800-0468-82</NDC11Code>
<ProductNDC>36800-468</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Antacid Calcium</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37808-468-80</NDCCode>
<PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (37808-468-80)</PackageDescription>
<NDC11Code>37808-0468-80</NDC11Code>
<ProductNDC>37808-468</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antacid</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970917</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>42829-468-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42829-468-02) / 7 g in 1 TUBE</PackageDescription>
<NDC11Code>42829-0468-02</NDC11Code>
<ProductNDC>42829-468</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zilactin</ProprietaryName>
<ProprietaryNameSuffix>Early Relief Cold Sore</ProprietaryNameSuffix>
<NonProprietaryName>Benzyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>BENZYL ALCOHOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves pain caused by: 1 cold sores/fever blisters, 2 canker sores, mouth sores, 3 gum irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-313-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-313-05) </PackageDescription>
<NDC11Code>43598-0313-05</NDC11Code>
<ProductNDC>43598-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43598-313-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-313-30) </PackageDescription>
<NDC11Code>43598-0313-30</NDC11Code>
<ProductNDC>43598-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43598-313-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-313-60) </PackageDescription>
<NDC11Code>43598-0313-60</NDC11Code>
<ProductNDC>43598-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43598-313-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43598-313-90) </PackageDescription>
<NDC11Code>43598-0313-90</NDC11Code>
<ProductNDC>43598-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43598-314-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-314-05) </PackageDescription>
<NDC11Code>43598-0314-05</NDC11Code>
<ProductNDC>43598-314</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
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<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2021-04-03</LastUpdate>
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<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
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<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43598-314-90) </PackageDescription>
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<StrengthNumber>5; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
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<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
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<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
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<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
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<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43598-315-90) </PackageDescription>
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<ProductNDC>43598-315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-316-05) </PackageDescription>
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<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
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