{
"NDC": [
{
"NDCCode": "43353-023-44",
"PackageDescription": "36 TABLET in 1 BOTTLE (43353-023-44) ",
"NDC11Code": "43353-0023-44",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150524",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "50881-023-11",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50881-023-11) / .44 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50881-0023-11",
"ProductNDC": "50881-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niktimvo",
"NonProprietaryName": "Axatilimab-csfr",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761411",
"LabelerName": "Incyte Corporation",
"SubstanceName": "AXATILIMAB",
"StrengthNumber": "22",
"StrengthUnit": "mg/.44mL",
"Pharm_Classes": "Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.",
"Description": "Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0."
},
{
"NDCCode": "53462-023-30",
"PackageDescription": "1 KIT in 1 KIT (53462-023-30) * 1 BOTTLE, PLASTIC in 1 KIT > 44 mL in 1 BOTTLE, PLASTIC (53462-075-30) * 1 TUBE in 1 KIT > 14 g in 1 TUBE",
"NDC11Code": "53462-0023-30",
"ProductNDC": "53462-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Short Term Oral Swab System",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20070630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Sage Products, LLC",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20070630",
"SamplePackage": "N"
},
{
"NDCCode": "63824-023-45",
"PackageDescription": "1 BOTTLE in 1 BLISTER PACK (63824-023-45) > 44 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "63824-0023-45",
"ProductNDC": "63824-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021282",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-10-17"
},
{
"NDCCode": "43353-023-11",
"PackageDescription": "48 TABLET in 1 BOTTLE (43353-023-11) ",
"NDC11Code": "43353-0023-11",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150620",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (43353-023-15) ",
"NDC11Code": "43353-0023-15",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (43353-023-20) ",
"NDC11Code": "43353-0023-20",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-21",
"PackageDescription": "32 TABLET in 1 BOTTLE (43353-023-21) ",
"NDC11Code": "43353-0023-21",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150524",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (43353-023-25) ",
"NDC11Code": "43353-0023-25",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (43353-023-28) ",
"NDC11Code": "43353-0023-28",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150516",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (43353-023-30) ",
"NDC11Code": "43353-0023-30",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-35",
"PackageDescription": "35 TABLET in 1 BOTTLE (43353-023-35) ",
"NDC11Code": "43353-0023-35",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-38",
"PackageDescription": "55 TABLET in 1 BOTTLE (43353-023-38) ",
"NDC11Code": "43353-0023-38",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150515",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (43353-023-40) ",
"NDC11Code": "43353-0023-40",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (43353-023-45) ",
"NDC11Code": "43353-0023-45",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-46",
"PackageDescription": "56 TABLET in 1 BOTTLE (43353-023-46) ",
"NDC11Code": "43353-0023-46",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150621",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-47",
"PackageDescription": "24 TABLET in 1 BOTTLE (43353-023-47) ",
"NDC11Code": "43353-0023-47",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150524",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-50",
"PackageDescription": "50 TABLET in 1 BOTTLE (43353-023-50) ",
"NDC11Code": "43353-0023-50",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (43353-023-53) ",
"NDC11Code": "43353-0023-53",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-55",
"PackageDescription": "75 TABLET in 1 BOTTLE (43353-023-55) ",
"NDC11Code": "43353-0023-55",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-57",
"PackageDescription": "80 TABLET in 1 BOTTLE (43353-023-57) ",
"NDC11Code": "43353-0023-57",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150517",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-59",
"PackageDescription": "22 TABLET in 1 BOTTLE (43353-023-59) ",
"NDC11Code": "43353-0023-59",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150524",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (43353-023-60) ",
"NDC11Code": "43353-0023-60",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-61",
"PackageDescription": "70 TABLET in 1 BOTTLE (43353-023-61) ",
"NDC11Code": "43353-0023-61",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150515",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-65",
"PackageDescription": "100 TABLET in 1 BOTTLE (43353-023-65) ",
"NDC11Code": "43353-0023-65",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150517",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-68",
"PackageDescription": "26 TABLET in 1 BOTTLE (43353-023-68) ",
"NDC11Code": "43353-0023-68",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150508",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-70",
"PackageDescription": "120 TABLET in 1 BOTTLE (43353-023-70) ",
"NDC11Code": "43353-0023-70",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150516",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "43353-023-78",
"PackageDescription": "34 TABLET in 1 BOTTLE (43353-023-78) ",
"NDC11Code": "43353-0023-78",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150522",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "0006-5084-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) ",
"NDC11Code": "00006-5084-01",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0006-5084-59",
"PackageDescription": "1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) ",
"NDC11Code": "00006-5084-59",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "Y",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
}
]
}
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<PackageDescription>36 TABLET in 1 BOTTLE (43353-023-44) </PackageDescription>
<NDC11Code>43353-0023-44</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
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<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50881-023-11) / .44 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50881-0023-11</NDC11Code>
<ProductNDC>50881-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niktimvo</ProprietaryName>
<NonProprietaryName>Axatilimab-csfr</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761411</ApplicationNumber>
<LabelerName>Incyte Corporation</LabelerName>
<SubstanceName>AXATILIMAB</SubstanceName>
<StrengthNumber>22</StrengthNumber>
<StrengthUnit>mg/.44mL</StrengthUnit>
<Pharm_Classes>Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa. NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles. Each single-dose vial contains 9 mg or 22 mg of axatilimab-csfr at a concentration of 10 mg/mL or 50 mg/mL. Each mL of solution contains citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0.</Description>
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<NDC11Code>53462-0023-30</NDC11Code>
<ProductNDC>53462-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Short Term Oral Swab System</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20070630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Sage Products, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>63824-023-45</NDCCode>
<PackageDescription>1 BOTTLE in 1 BLISTER PACK (63824-023-45) > 44 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>63824-0023-45</NDC11Code>
<ProductNDC>63824-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120626</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021282</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-10-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-023-11</NDCCode>
<PackageDescription>48 TABLET in 1 BOTTLE (43353-023-11) </PackageDescription>
<NDC11Code>43353-0023-11</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (43353-023-15) </PackageDescription>
<NDC11Code>43353-0023-15</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (43353-023-20) </PackageDescription>
<NDC11Code>43353-0023-20</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-21</NDCCode>
<PackageDescription>32 TABLET in 1 BOTTLE (43353-023-21) </PackageDescription>
<NDC11Code>43353-0023-21</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (43353-023-25) </PackageDescription>
<NDC11Code>43353-0023-25</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (43353-023-28) </PackageDescription>
<NDC11Code>43353-0023-28</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43353-023-30) </PackageDescription>
<NDC11Code>43353-0023-30</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-35</NDCCode>
<PackageDescription>35 TABLET in 1 BOTTLE (43353-023-35) </PackageDescription>
<NDC11Code>43353-0023-35</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-38</NDCCode>
<PackageDescription>55 TABLET in 1 BOTTLE (43353-023-38) </PackageDescription>
<NDC11Code>43353-0023-38</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (43353-023-40) </PackageDescription>
<NDC11Code>43353-0023-40</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE (43353-023-45) </PackageDescription>
<NDC11Code>43353-0023-45</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-46</NDCCode>
<PackageDescription>56 TABLET in 1 BOTTLE (43353-023-46) </PackageDescription>
<NDC11Code>43353-0023-46</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-47</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (43353-023-47) </PackageDescription>
<NDC11Code>43353-0023-47</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-50</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (43353-023-50) </PackageDescription>
<NDC11Code>43353-0023-50</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (43353-023-53) </PackageDescription>
<NDC11Code>43353-0023-53</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-55</NDCCode>
<PackageDescription>75 TABLET in 1 BOTTLE (43353-023-55) </PackageDescription>
<NDC11Code>43353-0023-55</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-57</NDCCode>
<PackageDescription>80 TABLET in 1 BOTTLE (43353-023-57) </PackageDescription>
<NDC11Code>43353-0023-57</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-59</NDCCode>
<PackageDescription>22 TABLET in 1 BOTTLE (43353-023-59) </PackageDescription>
<NDC11Code>43353-0023-59</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43353-023-60) </PackageDescription>
<NDC11Code>43353-0023-60</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-61</NDCCode>
<PackageDescription>70 TABLET in 1 BOTTLE (43353-023-61) </PackageDescription>
<NDC11Code>43353-0023-61</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-65</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43353-023-65) </PackageDescription>
<NDC11Code>43353-0023-65</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-68</NDCCode>
<PackageDescription>26 TABLET in 1 BOTTLE (43353-023-68) </PackageDescription>
<NDC11Code>43353-0023-68</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-70</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (43353-023-70) </PackageDescription>
<NDC11Code>43353-0023-70</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-78</NDCCode>
<PackageDescription>34 TABLET in 1 BOTTLE (43353-023-78) </PackageDescription>
<NDC11Code>43353-0023-78</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) </PackageDescription>
<NDC11Code>00006-5084-01</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-59</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) </PackageDescription>
<NDC11Code>00006-5084-59</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
</NDCList>