{
"NDC": [
{
"NDCCode": "0024-5918-01",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5918-01) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-00) ",
"NDC11Code": "00024-5918-01",
"ProductNDC": "0024-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dupixent",
"NonProprietaryName": "Dupilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761055",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DUPILUMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N",
"IndicationAndUsage": "DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).",
"Description": "Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9."
},
{
"NDCCode": "0024-5918-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5918-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-20) ",
"NDC11Code": "00024-5918-02",
"ProductNDC": "0024-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dupixent",
"NonProprietaryName": "Dupilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761055",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DUPILUMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N",
"IndicationAndUsage": "DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).",
"Description": "Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9."
},
{
"NDCCode": "54868-5918-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (54868-5918-1)",
"NDC11Code": "54868-5918-01",
"ProductNDC": "54868-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079088",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Enter section text here.",
"Description": "Risperidone tablets, USP, contain risperidone, USP, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&C yellow # 6 Orange yellow S (E 110). 4 mg tablets: FD&C Blue # 2 Lake of indigo carmine."
},
{
"NDCCode": "61567-002-01",
"PackageDescription": "5918 L in 1 CYLINDER (61567-002-01) ",
"NDC11Code": "61567-0002-01",
"ProductNDC": "61567-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205891",
"LabelerName": "Ali-Rob, Inc. dba Southern Oxygen & Welding Supply",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N"
},
{
"NDCCode": "0299-5918-02",
"PackageDescription": "2 g in 1 TUBE (0299-5918-02) ",
"NDC11Code": "00299-5918-02",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5918-15",
"PackageDescription": "1 TUBE in 1 CARTON (0299-5918-15) > 15 g in 1 TUBE",
"NDC11Code": "00299-5918-15",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5918-25",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0299-5918-25) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "00299-5918-25",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"EndMarketingDate": "20270201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090915",
"EndMarketingDatePackage": "20270201",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0299-5918-45",
"PackageDescription": "1 TUBE in 1 CARTON (0299-5918-45) > 45 g in 1 TUBE",
"NDC11Code": "00299-5918-45",
"ProductNDC": "0299-5918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Differin",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021753",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N",
"IndicationAndUsage": "DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
},
{
"NDCCode": "0009-0024-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0009-0024-01)",
"NDC11Code": "00009-0024-01",
"ProductNDC": "0009-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Didrex",
"NonProprietaryName": "Benzphetamine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19601026",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012427",
"LabelerName": "Pharmacia and Upjohn Company",
"SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0024-0654-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00024-0654-01",
"ProductNDC": "0024-0654",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sarclisa",
"NonProprietaryName": "Isatuximab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761113",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ISATUXIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "SARCLISA is indicated: 1 in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor., 2 in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy., 3 in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).",
"Description": "Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. SARCLISA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particles in a single-dose vial for intravenous use. Each vial contains either 100 mg/5 mL or 500 mg/25 mL of isatuximab-irfc at a concentration of 20 mg/mL with a pH of 6.0. Each mL of solution contains 20 mg isatuximab-irfc, histidine (1.46 mg), histidine hydrochloride monohydrate (2.22 mg), polysorbate 80 (0.2 mg), sucrose (100 mg), and water for injection."
},
{
"NDCCode": "0024-0656-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0656-01) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00024-0656-01",
"ProductNDC": "0024-0656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sarclisa",
"NonProprietaryName": "Isatuximab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761113",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ISATUXIMAB",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "SARCLISA is indicated: 1 in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor., 2 in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy., 3 in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).",
"Description": "Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. SARCLISA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particles in a single-dose vial for intravenous use. Each vial contains either 100 mg/5 mL or 500 mg/25 mL of isatuximab-irfc at a concentration of 20 mg/mL with a pH of 6.0. Each mL of solution contains 20 mg isatuximab-irfc, histidine (1.46 mg), histidine hydrochloride monohydrate (2.22 mg), polysorbate 80 (0.2 mg), sucrose (100 mg), and water for injection."
},
{
"NDCCode": "0024-0674-01",
"PackageDescription": "1 VIAL in 1 CARTON (0024-0674-01) / 10 mL in 1 VIAL",
"NDC11Code": "00024-0674-01",
"ProductNDC": "0024-0674",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sarclisa Escena",
"NonProprietaryName": "Isatuximab-irfc",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260709",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761445",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ISATUXIMAB",
"StrengthNumber": "140",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260709",
"SamplePackage": "N",
"IndicationAndUsage": "SARCLISA ESCENA is indicated: 1 in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor., 2 in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy., 3 in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).",
"Description": "Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. SARCLISA ESCENA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, in a single-dose vial for subcutaneous use. Each vial contains 1,400 mg/10 mL at a concentration of 140 mg/mL with a pH of 6.2. Each mL of solution contains 140 mg isatuximab-irfc, arginine hydrochloride (23.2 mg), histidine (0.82 mg), histidine hydrochloride monohydrate (0.78 mg), poloxamer 188 (4.0 mg), sucrose (20.0 mg), and Water for Injection, USP."
},
{
"NDCCode": "0024-1596-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01) ",
"NDC11Code": "00024-1596-01",
"ProductNDC": "0024-1596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primaquine Phosphate",
"NonProprietaryName": "Primaquine Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA008316",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "PRIMAQUINE PHOSPHATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110415",
"SamplePackage": "N",
"IndicationAndUsage": "Primaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.",
"Description": "Primaquine phosphate is 8-[(4-amino-1-methylbutyl) amino]-6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. The molecular formula of Primaquine phosphate is C15H21N3O∙2H3PO4 and its molecular weight is 455.34. The structural formula of Primaquine phosphate is. Figure 1: Primaquine phosphate structure. Each Primaquine phosphate tablet contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Carnauba Wax, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 400, Polysorbate 80, Pregelatinized Starch, Red Ferric Oxide, Talc, Titanium Dioxide."
},
{
"NDCCode": "0024-2792-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01) ",
"NDC11Code": "00024-2792-10",
"ProductNDC": "0024-2792",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ferrlecit",
"NonProprietaryName": "Sodium Ferric Gluconate Complex",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020955",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "SODIUM FERRIC GLUCONATE COMPLEX",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110301",
"SamplePackage": "N",
"IndicationAndUsage": "Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.",
"Description": "Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient."
},
{
"NDCCode": "0024-2794-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01) ",
"NDC11Code": "00024-2794-10",
"ProductNDC": "0024-2794",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ferrlecit",
"NonProprietaryName": "Sodium Ferric Gluconate Complex",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140707",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020955",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "SODIUM FERRIC GLUCONATE COMPLEX",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140707",
"SamplePackage": "N",
"IndicationAndUsage": "Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.",
"Description": "Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient."
},
{
"NDCCode": "0024-5745-02",
"PackageDescription": "1 KIT in 1 CARTON (0024-5745-02) * 3 mL in 1 SYRINGE (0024-5741-01) * 3 mL in 1 SYRINGE (0024-5740-00) ",
"NDC11Code": "00024-5745-02",
"ProductNDC": "0024-5745",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlyxin",
"NonProprietaryName": "Lixisenatide",
"DosageFormName": "KIT",
"StartMarketingDate": "20160727",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208471",
"LabelerName": "sanofi-aventis U.S. LLC",
"Status": "Deprecated",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160727",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5761-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5761-01",
"ProductNDC": "0024-5761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soliqua 100/33",
"NonProprietaryName": "Insulin Glargine And Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208673",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE; LIXISENATIDE",
"StrengthNumber": "100; 33",
"StrengthUnit": "U/mL; ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N",
"IndicationAndUsage": "SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5."
},
{
"NDCCode": "0024-5824-11",
"PackageDescription": "1 KIT in 1 CARTON (0024-5824-11) * 5.7 mL in 1 VIAL, GLASS (0024-5823-15) * 5.7 mL in 1 VIAL, GLASS (0024-5822-01) ",
"NDC11Code": "00024-5824-11",
"ProductNDC": "0024-5824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jevtana",
"NonProprietaryName": "Cabazitaxel",
"DosageFormName": "KIT",
"StartMarketingDate": "20100617",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201023",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100617",
"SamplePackage": "N",
"IndicationAndUsage": "JEVTANA® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.",
"Description": "JEVTANA (cabazitaxel) injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. It is prepared by semi-synthesis with a precursor extracted from yew needles. The chemical name of cabazitaxel is (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-[(tertbutoxycarbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate – propan-2-one (1:1). Cabazitaxel has the following structural formula. Cabazitaxel is a white to almost-white powder with a molecular formula of C45H57NO14C3H6O and a molecular weight of 894.01 (for the acetone solvate) / 835.93 (for the solvent free). It is lipophilic, practically insoluble in water and soluble in alcohol. JEVTANA (cabazitaxel) injection 60 mg/1.5 mL is a sterile, non-pyrogenic, clear yellow to brownish-yellow viscous solution and is available in single-dose vials containing 60 mg cabazitaxel (anhydrous and solvent free) and 1.56 g polysorbate 80 (citric acid monohydrate is used to adjust the pH of the polysorbate 80 between 3.3 to 3.8). Each mL contains 40 mg cabazitaxel (anhydrous) and 1.04 g polysorbate 80. DILUENT for JEVTANA is a clear, colorless, sterile, and non-pyrogenic solution containing 13% (w/w) ethanol in water for injection, approximately 5.7 mL. JEVTANA requires two dilutions prior to intravenous infusion. JEVTANA injection should be diluted only with the supplied DILUENT for JEVTANA, followed by dilution in either 0.9% sodium chloride solution or 5% dextrose solution."
},
{
"NDCCode": "0024-5837-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0024-5837-01) ",
"NDC11Code": "00024-5837-01",
"ProductNDC": "0024-5837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flomax",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970912",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020579",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970912",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "FLOMAX (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. FLOMAX capsules are not indicated for the treatment of hypertension.",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C20H28N2O5S ∙ HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each FLOMAX capsule for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose; methacrylic acid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; iron oxide; FD&C blue No. 2; titanium dioxide; propylene glycol; and shellac."
},
{
"NDCCode": "0024-5840-01",
"PackageDescription": "1 VIAL in 1 CARTON (0024-5840-01) / 4 mL in 1 VIAL",
"NDC11Code": "00024-5840-01",
"ProductNDC": "0024-5840",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zaltrap",
"NonProprietaryName": "Ziv-aflibercept",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120803",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125418",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120803",
"SamplePackage": "N",
"IndicationAndUsage": "ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.",
"Description": "Ziv-aflibercept is a vascular endothelial growth factor inhibitor. It is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. ZALTRAP (ziv-aflibercept) injection is a sterile, clear, colorless to pale-yellow, non-pyrogenic, preservative-free, solution for intravenous use. ZALTRAP is supplied in single-dose vials of 100 mg/4 mL and 200 mg/8 mL formulated as 25 mg/mL ziv-aflibercept in polysorbate 20 (1 mg/mL), sodium chloride (5.84 mg/mL), sodium citrate (1.45 mg/mL), sodium phosphate (0.8 mg/mL), and sucrose (200 mg/mL), in Water for Injection, USP, at a pH of 6.2."
},
{
"NDCCode": "0024-5841-01",
"PackageDescription": "1 VIAL in 1 CARTON (0024-5841-01) / 8 mL in 1 VIAL",
"NDC11Code": "00024-5841-01",
"ProductNDC": "0024-5841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zaltrap",
"NonProprietaryName": "Ziv-aflibercept",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120803",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125418",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "200",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120803",
"SamplePackage": "N",
"IndicationAndUsage": "ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.",
"Description": "Ziv-aflibercept is a vascular endothelial growth factor inhibitor. It is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. ZALTRAP (ziv-aflibercept) injection is a sterile, clear, colorless to pale-yellow, non-pyrogenic, preservative-free, solution for intravenous use. ZALTRAP is supplied in single-dose vials of 100 mg/4 mL and 200 mg/8 mL formulated as 25 mg/mL ziv-aflibercept in polysorbate 20 (1 mg/mL), sodium chloride (5.84 mg/mL), sodium citrate (1.45 mg/mL), sodium phosphate (0.8 mg/mL), and sucrose (200 mg/mL), in Water for Injection, USP, at a pH of 6.2."
},
{
"NDCCode": "0024-5843-05",
"PackageDescription": "5 VIAL in 1 CARTON (0024-5843-05) > 1 mL in 1 VIAL (0024-5843-01) ",
"NDC11Code": "00024-5843-05",
"ProductNDC": "0024-5843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leukine",
"NonProprietaryName": "Sargramostim",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "19910501",
"EndMarketingDate": "20211230",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103362",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "SARGRAMOSTIM",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19910501",
"EndMarketingDatePackage": "20211230",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5844-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0024-5844-01) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00024-5844-01",
"ProductNDC": "0024-5844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leukine",
"NonProprietaryName": "Sargramostim",
"DosageFormName": "LIQUID",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "19961201",
"EndMarketingDate": "20211230",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103362",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "SARGRAMOSTIM",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961201",
"EndMarketingDatePackage": "20211230",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5860-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 BOX (0024-5860-01) / 20 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00024-5860-01",
"ProductNDC": "0024-5860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clolar",
"NonProprietaryName": "Clofarabine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021673",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "CLOFARABINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130401",
"SamplePackage": "N",
"IndicationAndUsage": "Clolar® is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.",
"Description": "Clolar (clofarabine) injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is C10H11ClFN5O3 with a molecular weight of 303.68 Daltons. The molecular structure of clofarabine is. Clolar (1 mg/mL) is supplied in a 20 mL, single-dose vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free."
},
{
"NDCCode": "0024-5862-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00024-5862-01",
"ProductNDC": "0024-5862",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mozobil",
"NonProprietaryName": "Plerixafor",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022311",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "PLERIXAFOR",
"StrengthNumber": "24",
"StrengthUnit": "mg/1.2mL",
"Pharm_Classes": "Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130901",
"SamplePackage": "N",
"IndicationAndUsage": "Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).",
"Description": "Mozobil (plerixafor) injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C28H54N8. The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula. Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1."
},
{
"NDCCode": "0024-5869-03",
"PackageDescription": "3 SYRINGE in 1 CARTON (0024-5869-03) / 1.5 mL in 1 SYRINGE (0024-5869-01) ",
"NDC11Code": "00024-5869-03",
"ProductNDC": "0024-5869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150215",
"SamplePackage": "N",
"IndicationAndUsage": "TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.",
"Description": "Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4."
},
{
"NDCCode": "0024-5869-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0024-5869-05) > 1.5 mL in 1 SYRINGE (0024-5869-01)",
"NDC11Code": "00024-5869-05",
"ProductNDC": "0024-5869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0024-5871-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5871-01) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5871-01",
"ProductNDC": "0024-5871",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo Max",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "Y",
"IndicationAndUsage": "TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.",
"Description": "Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4."
},
{
"NDCCode": "0024-5901-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0024-5901-01) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5901-01",
"ProductNDC": "0024-5901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
},
{
"NDCCode": "0024-5902-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0024-5902-01) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5902-01",
"ProductNDC": "0024-5902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0024-5918-01</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5918-01) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-00) </PackageDescription>
<NDC11Code>00024-5918-01</NDC11Code>
<ProductNDC>0024-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761055</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DUPILUMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).</IndicationAndUsage>
<Description>Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.</Description>
</NDC>
<NDC>
<NDCCode>0024-5918-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5918-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-20) </PackageDescription>
<NDC11Code>00024-5918-02</NDC11Code>
<ProductNDC>0024-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761055</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DUPILUMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).</IndicationAndUsage>
<Description>Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.</Description>
</NDC>
<NDC>
<NDCCode>54868-5918-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (54868-5918-1)</PackageDescription>
<NDC11Code>54868-5918-01</NDC11Code>
<ProductNDC>54868-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079088</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Enter section text here.</IndicationAndUsage>
<Description>Risperidone tablets, USP, contain risperidone, USP, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&C yellow # 6 Orange yellow S (E 110). 4 mg tablets: FD&C Blue # 2 Lake of indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>61567-002-01</NDCCode>
<PackageDescription>5918 L in 1 CYLINDER (61567-002-01) </PackageDescription>
<NDC11Code>61567-0002-01</NDC11Code>
<ProductNDC>61567-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205891</ApplicationNumber>
<LabelerName>Ali-Rob, Inc. dba Southern Oxygen & Welding Supply</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0299-5918-02</NDCCode>
<PackageDescription>2 g in 1 TUBE (0299-5918-02) </PackageDescription>
<NDC11Code>00299-5918-02</NDC11Code>
<ProductNDC>0299-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Differin</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021753</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0299-5918-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-5918-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5918-15</NDC11Code>
<ProductNDC>0299-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Differin</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021753</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0299-5918-25</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0299-5918-25) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00299-5918-25</NDC11Code>
<ProductNDC>0299-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Differin</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090915</StartMarketingDate>
<EndMarketingDate>20270201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021753</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090915</StartMarketingDatePackage>
<EndMarketingDatePackage>20270201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0299-5918-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0299-5918-45) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00299-5918-45</NDC11Code>
<ProductNDC>0299-5918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Differin</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021753</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>DIFFERIN (adapalene) Gel contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0009-0024-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0009-0024-01)</PackageDescription>
<NDC11Code>00009-0024-01</NDC11Code>
<ProductNDC>0009-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Didrex</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19601026</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012427</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-0654-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00024-0654-01</NDC11Code>
<ProductNDC>0024-0654</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sarclisa</ProprietaryName>
<NonProprietaryName>Isatuximab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761113</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ISATUXIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SARCLISA is indicated: 1 in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor., 2 in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy., 3 in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).</IndicationAndUsage>
<Description>Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. SARCLISA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particles in a single-dose vial for intravenous use. Each vial contains either 100 mg/5 mL or 500 mg/25 mL of isatuximab-irfc at a concentration of 20 mg/mL with a pH of 6.0. Each mL of solution contains 20 mg isatuximab-irfc, histidine (1.46 mg), histidine hydrochloride monohydrate (2.22 mg), polysorbate 80 (0.2 mg), sucrose (100 mg), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0024-0656-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0656-01) / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00024-0656-01</NDC11Code>
<ProductNDC>0024-0656</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sarclisa</ProprietaryName>
<NonProprietaryName>Isatuximab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761113</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ISATUXIMAB</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/25mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SARCLISA is indicated: 1 in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor., 2 in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy., 3 in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).</IndicationAndUsage>
<Description>Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. SARCLISA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particles in a single-dose vial for intravenous use. Each vial contains either 100 mg/5 mL or 500 mg/25 mL of isatuximab-irfc at a concentration of 20 mg/mL with a pH of 6.0. Each mL of solution contains 20 mg isatuximab-irfc, histidine (1.46 mg), histidine hydrochloride monohydrate (2.22 mg), polysorbate 80 (0.2 mg), sucrose (100 mg), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0024-0674-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0024-0674-01) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00024-0674-01</NDC11Code>
<ProductNDC>0024-0674</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sarclisa Escena</ProprietaryName>
<NonProprietaryName>Isatuximab-irfc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260709</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761445</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ISATUXIMAB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SARCLISA ESCENA is indicated: 1 in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor., 2 in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy., 3 in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).</IndicationAndUsage>
<Description>Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. SARCLISA ESCENA (isatuximab-irfc) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, in a single-dose vial for subcutaneous use. Each vial contains 1,400 mg/10 mL at a concentration of 140 mg/mL with a pH of 6.2. Each mL of solution contains 140 mg isatuximab-irfc, arginine hydrochloride (23.2 mg), histidine (0.82 mg), histidine hydrochloride monohydrate (0.78 mg), poloxamer 188 (4.0 mg), sucrose (20.0 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-1596-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01) </PackageDescription>
<NDC11Code>00024-1596-01</NDC11Code>
<ProductNDC>0024-1596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primaquine Phosphate</ProprietaryName>
<NonProprietaryName>Primaquine Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA008316</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>PRIMAQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Primaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.</IndicationAndUsage>
<Description>Primaquine phosphate is 8-[(4-amino-1-methylbutyl) amino]-6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. The molecular formula of Primaquine phosphate is C15H21N3O∙2H3PO4 and its molecular weight is 455.34. The structural formula of Primaquine phosphate is. Figure 1: Primaquine phosphate structure. Each Primaquine phosphate tablet contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Carnauba Wax, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 400, Polysorbate 80, Pregelatinized Starch, Red Ferric Oxide, Talc, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0024-2792-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01) </PackageDescription>
<NDC11Code>00024-2792-10</NDC11Code>
<ProductNDC>0024-2792</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ferrlecit</ProprietaryName>
<NonProprietaryName>Sodium Ferric Gluconate Complex</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020955</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>SODIUM FERRIC GLUCONATE COMPLEX</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.</IndicationAndUsage>
<Description>Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>0024-2794-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01) </PackageDescription>
<NDC11Code>00024-2794-10</NDC11Code>
<ProductNDC>0024-2794</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ferrlecit</ProprietaryName>
<NonProprietaryName>Sodium Ferric Gluconate Complex</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020955</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>SODIUM FERRIC GLUCONATE COMPLEX</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.</IndicationAndUsage>
<Description>Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>0024-5745-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0024-5745-02) * 3 mL in 1 SYRINGE (0024-5741-01) * 3 mL in 1 SYRINGE (0024-5740-00) </PackageDescription>
<NDC11Code>00024-5745-02</NDC11Code>
<ProductNDC>0024-5745</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlyxin</ProprietaryName>
<NonProprietaryName>Lixisenatide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160727</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208471</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5761-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5761-01</NDC11Code>
<ProductNDC>0024-5761</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soliqua 100/33</ProprietaryName>
<NonProprietaryName>Insulin Glargine And Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208673</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE; LIXISENATIDE</SubstanceName>
<StrengthNumber>100; 33</StrengthNumber>
<StrengthUnit>U/mL; ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0024-5824-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0024-5824-11) * 5.7 mL in 1 VIAL, GLASS (0024-5823-15) * 5.7 mL in 1 VIAL, GLASS (0024-5822-01) </PackageDescription>
<NDC11Code>00024-5824-11</NDC11Code>
<ProductNDC>0024-5824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jevtana</ProprietaryName>
<NonProprietaryName>Cabazitaxel</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100617</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201023</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JEVTANA® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.</IndicationAndUsage>
<Description>JEVTANA (cabazitaxel) injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. It is prepared by semi-synthesis with a precursor extracted from yew needles. The chemical name of cabazitaxel is (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-[(tertbutoxycarbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate – propan-2-one (1:1). Cabazitaxel has the following structural formula. Cabazitaxel is a white to almost-white powder with a molecular formula of C45H57NO14C3H6O and a molecular weight of 894.01 (for the acetone solvate) / 835.93 (for the solvent free). It is lipophilic, practically insoluble in water and soluble in alcohol. JEVTANA (cabazitaxel) injection 60 mg/1.5 mL is a sterile, non-pyrogenic, clear yellow to brownish-yellow viscous solution and is available in single-dose vials containing 60 mg cabazitaxel (anhydrous and solvent free) and 1.56 g polysorbate 80 (citric acid monohydrate is used to adjust the pH of the polysorbate 80 between 3.3 to 3.8). Each mL contains 40 mg cabazitaxel (anhydrous) and 1.04 g polysorbate 80. DILUENT for JEVTANA is a clear, colorless, sterile, and non-pyrogenic solution containing 13% (w/w) ethanol in water for injection, approximately 5.7 mL. JEVTANA requires two dilutions prior to intravenous infusion. JEVTANA injection should be diluted only with the supplied DILUENT for JEVTANA, followed by dilution in either 0.9% sodium chloride solution or 5% dextrose solution.</Description>
</NDC>
<NDC>
<NDCCode>0024-5837-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0024-5837-01) </PackageDescription>
<NDC11Code>00024-5837-01</NDC11Code>
<ProductNDC>0024-5837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flomax</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970912</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020579</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970912</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FLOMAX (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. FLOMAX capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C20H28N2O5S ∙ HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each FLOMAX capsule for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose; methacrylic acid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; iron oxide; FD&C blue No. 2; titanium dioxide; propylene glycol; and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0024-5840-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0024-5840-01) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>00024-5840-01</NDC11Code>
<ProductNDC>0024-5840</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zaltrap</ProprietaryName>
<NonProprietaryName>Ziv-aflibercept</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120803</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125418</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.</IndicationAndUsage>
<Description>Ziv-aflibercept is a vascular endothelial growth factor inhibitor. It is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. ZALTRAP (ziv-aflibercept) injection is a sterile, clear, colorless to pale-yellow, non-pyrogenic, preservative-free, solution for intravenous use. ZALTRAP is supplied in single-dose vials of 100 mg/4 mL and 200 mg/8 mL formulated as 25 mg/mL ziv-aflibercept in polysorbate 20 (1 mg/mL), sodium chloride (5.84 mg/mL), sodium citrate (1.45 mg/mL), sodium phosphate (0.8 mg/mL), and sucrose (200 mg/mL), in Water for Injection, USP, at a pH of 6.2.</Description>
</NDC>
<NDC>
<NDCCode>0024-5841-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0024-5841-01) / 8 mL in 1 VIAL</PackageDescription>
<NDC11Code>00024-5841-01</NDC11Code>
<ProductNDC>0024-5841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zaltrap</ProprietaryName>
<NonProprietaryName>Ziv-aflibercept</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120803</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125418</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.</IndicationAndUsage>
<Description>Ziv-aflibercept is a vascular endothelial growth factor inhibitor. It is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. ZALTRAP (ziv-aflibercept) injection is a sterile, clear, colorless to pale-yellow, non-pyrogenic, preservative-free, solution for intravenous use. ZALTRAP is supplied in single-dose vials of 100 mg/4 mL and 200 mg/8 mL formulated as 25 mg/mL ziv-aflibercept in polysorbate 20 (1 mg/mL), sodium chloride (5.84 mg/mL), sodium citrate (1.45 mg/mL), sodium phosphate (0.8 mg/mL), and sucrose (200 mg/mL), in Water for Injection, USP, at a pH of 6.2.</Description>
</NDC>
<NDC>
<NDCCode>0024-5843-05</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (0024-5843-05) > 1 mL in 1 VIAL (0024-5843-01) </PackageDescription>
<NDC11Code>00024-5843-05</NDC11Code>
<ProductNDC>0024-5843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leukine</ProprietaryName>
<NonProprietaryName>Sargramostim</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19910501</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103362</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>SARGRAMOSTIM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19910501</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5844-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0024-5844-01) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00024-5844-01</NDC11Code>
<ProductNDC>0024-5844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leukine</ProprietaryName>
<NonProprietaryName>Sargramostim</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19961201</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103362</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>SARGRAMOSTIM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961201</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5860-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 BOX (0024-5860-01) / 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00024-5860-01</NDC11Code>
<ProductNDC>0024-5860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clolar</ProprietaryName>
<NonProprietaryName>Clofarabine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021673</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>CLOFARABINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clolar® is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.</IndicationAndUsage>
<Description>Clolar (clofarabine) injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is C10H11ClFN5O3 with a molecular weight of 303.68 Daltons. The molecular structure of clofarabine is. Clolar (1 mg/mL) is supplied in a 20 mL, single-dose vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5862-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00024-5862-01</NDC11Code>
<ProductNDC>0024-5862</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mozobil</ProprietaryName>
<NonProprietaryName>Plerixafor</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022311</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>PLERIXAFOR</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1.2mL</StrengthUnit>
<Pharm_Classes>Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).</IndicationAndUsage>
<Description>Mozobil (plerixafor) injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C28H54N8. The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula. Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1.</Description>
</NDC>
<NDC>
<NDCCode>0024-5869-03</NDCCode>
<PackageDescription>3 SYRINGE in 1 CARTON (0024-5869-03) / 1.5 mL in 1 SYRINGE (0024-5869-01) </PackageDescription>
<NDC11Code>00024-5869-03</NDC11Code>
<ProductNDC>0024-5869</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>0024-5869-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0024-5869-05) > 1.5 mL in 1 SYRINGE (0024-5869-01)</PackageDescription>
<NDC11Code>00024-5869-05</NDC11Code>
<ProductNDC>0024-5869</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin [Chemical/Ingredient],Insulin Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0024-5871-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5871-01) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5871-01</NDC11Code>
<ProductNDC>0024-5871</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo Max</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>0024-5901-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0024-5901-01) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5901-01</NDC11Code>
<ProductNDC>0024-5901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0024-5902-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0024-5902-01) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5902-01</NDC11Code>
<ProductNDC>0024-5902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
</NDCList>