{
"NDC": [
{
"NDCCode": "65597-903-60",
"PackageDescription": "60 PACKET in 1 CARTON (65597-903-60) > 1 FOR SUSPENSION in 1 PACKET",
"NDC11Code": "65597-0903-60",
"ProductNDC": "65597-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Welchol",
"NonProprietaryName": "Colesevelam Hydrochloride",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022362",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "1.875",
"StrengthUnit": "g/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "N"
},
{
"NDCCode": "35000-903-60",
"PackageDescription": "1 TUBE in 1 CARTON (35000-903-60) / 170 g in 1 TUBE",
"NDC11Code": "35000-0903-60",
"ProductNDC": "35000-903",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Max Fresh Cool Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20110801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110801",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35356-903-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (35356-903-60) ",
"NDC11Code": "35356-0903-60",
"ProductNDC": "35356-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077309",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130921",
"SamplePackage": "N"
},
{
"NDCCode": "49527-903-60",
"PackageDescription": "1 kg in 1 PAIL (49527-903-60) ",
"NDC11Code": "49527-0903-60",
"ProductNDC": "49527-903",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "CLINIQUE LABORATORIES LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "24; 59",
"StrengthUnit": "g/kg; g/kg",
"Status": "Unfinished",
"LastUpdate": "2026-08-06",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "05-AUG-26"
},
{
"NDCCode": "51316-903-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51316-903-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "51316-0903-06",
"ProductNDC": "51316-903",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health Stool Softener Plus Stimulant Laxative Softgel",
"NonProprietaryName": "Docusate Sodium, Sennosides",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240117",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240117",
"SamplePackage": "N",
"IndicationAndUsage": " relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "52747-903-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (52747-903-60)",
"NDC11Code": "52747-0903-60",
"ProductNDC": "52747-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tandem Ob",
"NonProprietaryName": "Vitamin Mineral Supplement",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060617",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "US Pharmaceutical Corporation",
"SubstanceName": "FERROUS FUMARATE; IRON; SODIUM ASCORBATE; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; CALCIUM PANTOTHENATE; MAGNESIUM SULFATE; CUPRIC SULFATE",
"StrengthNumber": "162; 115.2; 200; 10; 6; 5; 15; 1; 30; 10; 1.3; .8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-02-27",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52985-903-03",
"PackageDescription": "120 BOTTLE in 1 BOX (52985-903-03) > 60 mL in 1 BOTTLE",
"NDC11Code": "52985-0903-03",
"ProductNDC": "52985-903",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200618",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Anhui Oasis Disinfection Products Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200618",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the hands To help decrease bacteria on the skin when water, soap and towel are not available."
},
{
"NDCCode": "61919-903-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (61919-903-60) ",
"NDC11Code": "61919-0903-60",
"ProductNDC": "61919-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Direct_Rx",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man. Close.",
"Description": "Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid. Close."
},
{
"NDCCode": "62135-903-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62135-903-60) ",
"NDC11Code": "62135-0903-60",
"ProductNDC": "62135-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207797",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230104",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild to moderate dementia of the Alzheimer’s type ( 1.1) , 2 Mild to moderate dementia associated with Parkinson’s disease ( 1.2) .",
"Description": "Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C 14H 22N 2O 2 C 4H 6O 6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine Tartrate Capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and yellow iron oxide. The 3 mg, 4.5 mg and 6 mg capsules contain red iron oxide. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "67046-903-60",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-903-60)",
"NDC11Code": "67046-0903-60",
"ProductNDC": "67046-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088628",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia, , 2 Have not been tolerated, or are not expected to be tolerated. .",
"Description": "Acetaminophen and codeine phosphate are supplied in tablet form for oral administration. Acetaminophen, USP, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M.W. 151.16. Codeine phosphate, USP, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C 18H 21NO 3H 3PO 4½H 2O M.W. 406.37. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/15 mg) contains: 1 Acetaminophen, USP...........................300 mg Codeine Phosphate, USP.......................15 mg ."
},
{
"NDCCode": "71205-903-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-903-60) ",
"NDC11Code": "71205-0903-60",
"ProductNDC": "71205-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205229",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210720",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone and the following inactive ingredients: peanut oil, gelatin, glycerin, soya lecithin, titanium dioxide, and triglyderides medium chain."
},
{
"NDCCode": "77368-903-02",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (77368-903-02) ",
"NDC11Code": "77368-0903-02",
"ProductNDC": "77368-903",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nurinse Hand Sanitizer-q",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NuGenTec",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "65597-201-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (65597-201-07) ",
"NDC11Code": "65597-0201-07",
"ProductNDC": "65597-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-201-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-10) ",
"NDC11Code": "65597-0201-10",
"ProductNDC": "65597-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-201-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65597-201-30) ",
"NDC11Code": "65597-0201-30",
"ProductNDC": "65597-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-201-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65597-201-50) ",
"NDC11Code": "65597-0201-50",
"ProductNDC": "65597-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-201-70",
"PackageDescription": "7 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-70) ",
"NDC11Code": "65597-0201-70",
"ProductNDC": "65597-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-201-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65597-201-90) ",
"NDC11Code": "65597-0201-90",
"ProductNDC": "65597-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-202-05",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (65597-202-05) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "65597-0202-05",
"ProductNDC": "65597-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-202-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (65597-202-07) ",
"NDC11Code": "65597-0202-07",
"ProductNDC": "65597-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-202-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (65597-202-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "65597-0202-10",
"ProductNDC": "65597-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-202-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65597-202-30) ",
"NDC11Code": "65597-0202-30",
"ProductNDC": "65597-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-202-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65597-202-50) ",
"NDC11Code": "65597-0202-50",
"ProductNDC": "65597-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206316",
"LabelerName": "Daiichi Sankyo Inc.",
"SubstanceName": "EDOXABAN TOSYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
"NDCCode": "65597-202-70",
"PackageDescription": "7 TABLET, FILM COATED in 1 BLISTER PACK (65597-202-70) ",
"NDC11Code": "65597-0202-70",
"ProductNDC": "65597-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savaysa",
"NonProprietaryName": "Edoxaban Tosylate",
"DosageFormName": "TABLET, FILM COATED",
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"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
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"ProductNDC": "65597-203",
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"LabelerName": "Daiichi Sankyo Inc.",
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"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
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"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
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"LabelerName": "Daiichi Sankyo Inc.",
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"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
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"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
},
{
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"IndicationAndUsage": "SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).",
"Description": "Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets)."
}
]
}
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<LastUpdate>2026-08-06</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-AUG-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51316-903-06</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51316-903-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>51316-0903-06</NDC11Code>
<ProductNDC>51316-903</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health Stool Softener Plus Stimulant Laxative Softgel</ProprietaryName>
<NonProprietaryName>Docusate Sodium, Sennosides</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52747-903-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (52747-903-60)</PackageDescription>
<NDC11Code>52747-0903-60</NDC11Code>
<ProductNDC>52747-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tandem Ob</ProprietaryName>
<NonProprietaryName>Vitamin Mineral Supplement</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060617</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>US Pharmaceutical Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; IRON; SODIUM ASCORBATE; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; CALCIUM PANTOTHENATE; MAGNESIUM SULFATE; CUPRIC SULFATE</SubstanceName>
<StrengthNumber>162; 115.2; 200; 10; 6; 5; 15; 1; 30; 10; 1.3; .8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-27</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52985-903-03</NDCCode>
<PackageDescription>120 BOTTLE in 1 BOX (52985-903-03) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>52985-0903-03</NDC11Code>
<ProductNDC>52985-903</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Anhui Oasis Disinfection Products Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the hands To help decrease bacteria on the skin when water, soap and towel are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61919-903-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (61919-903-60) </PackageDescription>
<NDC11Code>61919-0903-60</NDC11Code>
<ProductNDC>61919-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man. Close.</IndicationAndUsage>
<Description>Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid. Close.</Description>
</NDC>
<NDC>
<NDCCode>62135-903-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62135-903-60) </PackageDescription>
<NDC11Code>62135-0903-60</NDC11Code>
<ProductNDC>62135-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207797</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild to moderate dementia of the Alzheimer’s type ( 1.1) , 2 Mild to moderate dementia associated with Parkinson’s disease ( 1.2) .</IndicationAndUsage>
<Description>Rivastigmine tartrate, USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C 14H 22N 2O 2 C 4H 6O 6 (hydrogen tartrate salt–hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine Tartrate Capsules, USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and yellow iron oxide. The 3 mg, 4.5 mg and 6 mg capsules contain red iron oxide. Imprinting ink contains: shellac, propylene glycol, black iron oxide and potassium hydroxide. Rivastigmine tartrate capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>67046-903-60</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (67046-903-60)</PackageDescription>
<NDC11Code>67046-0903-60</NDC11Code>
<ProductNDC>67046-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088628</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia, , 2 Have not been tolerated, or are not expected to be tolerated. .</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate are supplied in tablet form for oral administration. Acetaminophen, USP, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M.W. 151.16. Codeine phosphate, USP, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C 18H 21NO 3H 3PO 4½H 2O M.W. 406.37. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/15 mg) contains: 1 Acetaminophen, USP...........................300 mg Codeine Phosphate, USP.......................15 mg .</Description>
</NDC>
<NDC>
<NDCCode>71205-903-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-903-60) </PackageDescription>
<NDC11Code>71205-0903-60</NDC11Code>
<ProductNDC>71205-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205229</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone and the following inactive ingredients: peanut oil, gelatin, glycerin, soya lecithin, titanium dioxide, and triglyderides medium chain.</Description>
</NDC>
<NDC>
<NDCCode>77368-903-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (77368-903-02) </PackageDescription>
<NDC11Code>77368-0903-02</NDC11Code>
<ProductNDC>77368-903</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nurinse Hand Sanitizer-q</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NuGenTec</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65597-201-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (65597-201-07) </PackageDescription>
<NDC11Code>65597-0201-07</NDC11Code>
<ProductNDC>65597-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-201-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-10) </PackageDescription>
<NDC11Code>65597-0201-10</NDC11Code>
<ProductNDC>65597-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-201-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65597-201-30) </PackageDescription>
<NDC11Code>65597-0201-30</NDC11Code>
<ProductNDC>65597-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-201-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65597-201-50) </PackageDescription>
<NDC11Code>65597-0201-50</NDC11Code>
<ProductNDC>65597-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-201-70</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-70) </PackageDescription>
<NDC11Code>65597-0201-70</NDC11Code>
<ProductNDC>65597-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-201-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65597-201-90) </PackageDescription>
<NDC11Code>65597-0201-90</NDC11Code>
<ProductNDC>65597-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-202-05</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 CARTON (65597-202-05) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65597-0202-05</NDC11Code>
<ProductNDC>65597-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-202-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (65597-202-07) </PackageDescription>
<NDC11Code>65597-0202-07</NDC11Code>
<ProductNDC>65597-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-202-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (65597-202-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65597-0202-10</NDC11Code>
<ProductNDC>65597-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-202-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65597-202-30) </PackageDescription>
<NDC11Code>65597-0202-30</NDC11Code>
<ProductNDC>65597-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-202-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65597-202-50) </PackageDescription>
<NDC11Code>65597-0202-50</NDC11Code>
<ProductNDC>65597-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
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<NDCCode>65597-202-70</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BLISTER PACK (65597-202-70) </PackageDescription>
<NDC11Code>65597-0202-70</NDC11Code>
<ProductNDC>65597-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
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<NDCCode>65597-202-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65597-202-90) </PackageDescription>
<NDC11Code>65597-0202-90</NDC11Code>
<ProductNDC>65597-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
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<NDCCode>65597-203-05</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 CARTON (65597-203-05) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65597-0203-05</NDC11Code>
<ProductNDC>65597-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-203-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (65597-203-07) </PackageDescription>
<NDC11Code>65597-0203-07</NDC11Code>
<ProductNDC>65597-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
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<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-203-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (65597-203-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65597-0203-10</NDC11Code>
<ProductNDC>65597-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
<NonProprietaryName>Edoxaban Tosylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-203-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65597-203-30) </PackageDescription>
<NDC11Code>65597-0203-30</NDC11Code>
<ProductNDC>65597-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
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<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65597-203-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65597-203-50) </PackageDescription>
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<ProductNDC>65597-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savaysa</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150112</StartMarketingDate>
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<ApplicationNumber>NDA206316</ApplicationNumber>
<LabelerName>Daiichi Sankyo Inc.</LabelerName>
<SubstanceName>EDOXABAN TOSYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SAVAYSA is a factor Xa inhibitor indicated. To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1): 1 Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1).</IndicationAndUsage>
<Description>Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S∙C7H8O3S∙H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is. It is a white to pale yellowish-white crystalline powder. The solubility of edoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly soluble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practically insoluble at pH 8 to 9. SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identification markings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains 40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).</Description>
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