{
"NDC": [
{
"NDCCode": "0024-5902-00",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0024-5902-00) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5902-00",
"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."
},
{
"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."
},
{
"NDCCode": "0024-5902-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5902-02) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5902-02",
"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": "Deprecated",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.",
"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": "50090-5902-0",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5902-0) ",
"NDC11Code": "50090-5902-00",
"ProductNDC": "50090-5902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212977",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220113",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated granules. The 10 mg, 20 mg, and 40 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 mg, 20 mg, and 40 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2."
},
{
"NDCCode": "54569-5902-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (54569-5902-0)",
"NDC11Code": "54569-5902-00",
"ProductNDC": "54569-5902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078414",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54868-5902-0",
"PackageDescription": "12 TABLET in 1 BOTTLE, PLASTIC (54868-5902-0)",
"NDC11Code": "54868-5902-00",
"ProductNDC": "54868-5902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077290",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets, USP, are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone hydrochloride tablet, USP, is an opioid analgesic. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). The tablets contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. The 5 mg tablet also contains D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, and hydrated alumina. The 10 mg tablet also contains D&C Red No. 27 aluminum lake, D&C Red No. 30 aluminum lake, and hydrated alumina. The 15 mg tablet also contains D&C Yellow No. 10 aluminum lake and hydrated alumina. The 20 mg tablet also contains FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Yellow No. 6 aluminum lake, and hydrated alumina. The 5 mg, 10 mg, 15 mg. 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg. 13.5 mg, 18.0 mg, and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "62670-5902-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-5902-0) ",
"NDC11Code": "62670-5902-00",
"ProductNDC": "62670-5902",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Youre The One",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201111",
"EndMarketingDate": "20210511",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201111",
"EndMarketingDatePackage": "20210511",
"SamplePackage": "N"
},
{
"NDCCode": "0024-4142-00",
"PackageDescription": "6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) ",
"NDC11Code": "00024-4142-00",
"ProductNDC": "0024-4142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multaq",
"NonProprietaryName": "Dronedarone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022425",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DRONEDARONE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240601",
"SamplePackage": "Y",
"IndicationAndUsage": "MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].",
"Description": "Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide."
},
{
"NDCCode": "0024-4142-06",
"PackageDescription": "8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) ",
"NDC11Code": "00024-4142-06",
"ProductNDC": "0024-4142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multaq",
"NonProprietaryName": "Dronedarone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022425",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DRONEDARONE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090701",
"SamplePackage": "Y",
"IndicationAndUsage": "MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].",
"Description": "Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide."
},
{
"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": "0024-5831-00",
"PackageDescription": "1 INJECTION in 1 CARTON (0024-5831-00)",
"NDC11Code": "00024-5831-00",
"ProductNDC": "0024-5831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20121115",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "0024-5833-00",
"PackageDescription": "1 INJECTION in 1 CARTON (0024-5833-00)",
"NDC11Code": "00024-5833-00",
"ProductNDC": "0024-5833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20121115",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "0024-5869-00",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5869-00) / 1.5 mL in 1 SYRINGE",
"NDC11Code": "00024-5869-00",
"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": "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": "0024-5871-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) ",
"NDC11Code": "00024-5871-02",
"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": "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": "0024-5901-00",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5901-00",
"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": "0024-5903-00",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0024-5903-00) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5903-00",
"ProductNDC": "0024-5903",
"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": "PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "Y"
},
{
"NDCCode": "0024-5904-00",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0024-5904-00) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5904-00",
"ProductNDC": "0024-5904",
"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": "PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "Y"
},
{
"NDCCode": "0024-5908-01",
"PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5908-01) / 1.14 mL in 1 SYRINGE (0024-5908-00) ",
"NDC11Code": "00024-5908-01",
"ProductNDC": "0024-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kevzara",
"NonProprietaryName": "Sarilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761037",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "SARILUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170522",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
"Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
},
{
"NDCCode": "0024-5910-01",
"PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5910-01) / 1.14 mL in 1 SYRINGE (0024-5910-00) ",
"NDC11Code": "00024-5910-01",
"ProductNDC": "0024-5910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kevzara",
"NonProprietaryName": "Sarilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761037",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "SARILUMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170522",
"SamplePackage": "N",
"IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
"Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
},
{
"NDCCode": "0024-5911-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5911-02) / .67 mL in 1 SYRINGE, GLASS (0024-5911-00) ",
"NDC11Code": "00024-5911-02",
"ProductNDC": "0024-5911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dupixent",
"NonProprietaryName": "Dupilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211020",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761055",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DUPILUMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/.67mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211020",
"EndMarketingDatePackage": "20260731",
"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": "0024-5914-01",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5914-01) / 2 mL in 1 SYRINGE, GLASS (0024-5914-00) ",
"NDC11Code": "00024-5914-01",
"ProductNDC": "0024-5914",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dupixent",
"NonProprietaryName": "Dupilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170328",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761055",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DUPILUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"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": "20170328",
"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": "0024-5915-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5915-02) / 2 mL in 1 SYRINGE, GLASS (0024-5915-00) ",
"NDC11Code": "00024-5915-02",
"ProductNDC": "0024-5915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dupixent",
"NonProprietaryName": "Dupilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200619",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761055",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DUPILUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"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": "20200619",
"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": "0024-5918-01",
"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."
},
{
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"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5919-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5919-00) ",
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"ProductNDC": "0024-5919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dupixent",
"NonProprietaryName": "Dupilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210614",
"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]",
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"LastUpdate": "2026-08-07",
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"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": "0024-5920-01",
"PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5920-01) / 1.14 mL in 1 SYRINGE (0024-5920-00) ",
"NDC11Code": "00024-5920-01",
"ProductNDC": "0024-5920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kevzara",
"NonProprietaryName": "Sarilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761037",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "SARILUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180413",
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"IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
"Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
},
{
"NDCCode": "0024-5922-01",
"PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5922-01) / 1.14 mL in 1 SYRINGE (0024-5922-00) ",
"NDC11Code": "00024-5922-01",
"ProductNDC": "0024-5922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kevzara",
"NonProprietaryName": "Sarilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761037",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "SARILUMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
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"IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
"Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
},
{
"NDCCode": "0024-5925-00",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5925-00) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5925-00",
"ProductNDC": "0024-5925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0024-5927-00",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0024-5927-00) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00024-5927-00",
"ProductNDC": "0024-5927",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Merilog",
"NonProprietaryName": "Insulin Aspart-szjj",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761325",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "N",
"IndicationAndUsage": "MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da. MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "0024-5928-05",
"PackageDescription": "5 SYRINGE in 1 BOX (0024-5928-05) / 3 mL in 1 SYRINGE (0024-5928-00) ",
"NDC11Code": "00024-5928-05",
"ProductNDC": "0024-5928",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Merilog",
"NonProprietaryName": "Insulin Aspart-szjj",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761325",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN ASPART",
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"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
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"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "N",
"IndicationAndUsage": "MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da. MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "11722-024-00",
"PackageDescription": "1 kg in 1 CARTON (11722-024-00)",
"NDC11Code": "11722-0024-00",
"ProductNDC": "11722-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dronedarone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110207",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pliva Hrvatska d.o.o.",
"SubstanceName": "DRONEDARONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
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<NDC>
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<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>
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<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>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.</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>50090-5902-0</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5902-0) </PackageDescription>
<NDC11Code>50090-5902-00</NDC11Code>
<ProductNDC>50090-5902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212977</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated granules. The 10 mg, 20 mg, and 40 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 mg, 20 mg, and 40 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>54569-5902-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54569-5902-0)</PackageDescription>
<NDC11Code>54569-5902-00</NDC11Code>
<ProductNDC>54569-5902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078414</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-5902-0</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE, PLASTIC (54868-5902-0)</PackageDescription>
<NDC11Code>54868-5902-00</NDC11Code>
<ProductNDC>54868-5902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077290</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets, USP, are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablet, USP, is an opioid analgesic. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). The tablets contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. The 5 mg tablet also contains D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, and hydrated alumina. The 10 mg tablet also contains D&C Red No. 27 aluminum lake, D&C Red No. 30 aluminum lake, and hydrated alumina. The 15 mg tablet also contains D&C Yellow No. 10 aluminum lake and hydrated alumina. The 20 mg tablet also contains FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Yellow No. 6 aluminum lake, and hydrated alumina. The 5 mg, 10 mg, 15 mg. 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg. 13.5 mg, 18.0 mg, and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>62670-5902-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-5902-0) </PackageDescription>
<NDC11Code>62670-5902-00</NDC11Code>
<ProductNDC>62670-5902</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Youre The One</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201111</StartMarketingDate>
<EndMarketingDate>20210511</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201111</StartMarketingDatePackage>
<EndMarketingDatePackage>20210511</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-4142-00</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) </PackageDescription>
<NDC11Code>00024-4142-00</NDC11Code>
<ProductNDC>0024-4142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multaq</ProprietaryName>
<NonProprietaryName>Dronedarone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022425</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DRONEDARONE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240601</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0024-4142-06</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) </PackageDescription>
<NDC11Code>00024-4142-06</NDC11Code>
<ProductNDC>0024-4142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multaq</ProprietaryName>
<NonProprietaryName>Dronedarone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022425</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DRONEDARONE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide.</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>0024-5831-00</NDCCode>
<PackageDescription>1 INJECTION in 1 CARTON (0024-5831-00)</PackageDescription>
<NDC11Code>00024-5831-00</NDC11Code>
<ProductNDC>0024-5831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-5833-00</NDCCode>
<PackageDescription>1 INJECTION in 1 CARTON (0024-5833-00)</PackageDescription>
<NDC11Code>00024-5833-00</NDC11Code>
<ProductNDC>0024-5833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-5869-00</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5869-00) / 1.5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5869-00</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>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>0024-5871-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) </PackageDescription>
<NDC11Code>00024-5871-02</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>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>0024-5901-00</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5901-00</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>
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<NDCCode>0024-5903-00</NDCCode>
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<NDC11Code>00024-5903-00</NDC11Code>
<ProductNDC>0024-5903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
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<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>PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5904-00</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0024-5904-00) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5904-00</NDC11Code>
<ProductNDC>0024-5904</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5908-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5908-01) / 1.14 mL in 1 SYRINGE (0024-5908-00) </PackageDescription>
<NDC11Code>00024-5908-01</NDC11Code>
<ProductNDC>0024-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5910-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5910-01) / 1.14 mL in 1 SYRINGE (0024-5910-00) </PackageDescription>
<NDC11Code>00024-5910-01</NDC11Code>
<ProductNDC>0024-5910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5911-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5911-02) / .67 mL in 1 SYRINGE, GLASS (0024-5911-00) </PackageDescription>
<NDC11Code>00024-5911-02</NDC11Code>
<ProductNDC>0024-5911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211020</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761055</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DUPILUMAB</SubstanceName>
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<StrengthUnit>mg/.67mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211020</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<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>0024-5914-01</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5914-01) / 2 mL in 1 SYRINGE, GLASS (0024-5914-00) </PackageDescription>
<NDC11Code>00024-5914-01</NDC11Code>
<ProductNDC>0024-5914</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170328</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761055</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DUPILUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</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>20170328</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>0024-5915-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5915-02) / 2 mL in 1 SYRINGE, GLASS (0024-5915-00) </PackageDescription>
<NDC11Code>00024-5915-02</NDC11Code>
<ProductNDC>0024-5915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200619</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761055</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DUPILUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</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>20200619</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>
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<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<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>0024-5919-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5919-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5919-00) </PackageDescription>
<NDC11Code>00024-5919-02</NDC11Code>
<ProductNDC>0024-5919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210614</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>20210614</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>0024-5920-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5920-01) / 1.14 mL in 1 SYRINGE (0024-5920-00) </PackageDescription>
<NDC11Code>00024-5920-01</NDC11Code>
<ProductNDC>0024-5920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5922-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5922-01) / 1.14 mL in 1 SYRINGE (0024-5922-00) </PackageDescription>
<NDC11Code>00024-5922-01</NDC11Code>
<ProductNDC>0024-5922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5925-00</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5925-00) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5925-00</NDC11Code>
<ProductNDC>0024-5925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5927-00</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0024-5927-00) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00024-5927-00</NDC11Code>
<ProductNDC>0024-5927</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Merilog</ProprietaryName>
<NonProprietaryName>Insulin Aspart-szjj</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761325</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da. MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0024-5928-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 BOX (0024-5928-05) / 3 mL in 1 SYRINGE (0024-5928-00) </PackageDescription>
<NDC11Code>00024-5928-05</NDC11Code>
<ProductNDC>0024-5928</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Merilog</ProprietaryName>
<NonProprietaryName>Insulin Aspart-szjj</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761325</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da. MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>11722-024-00</NDCCode>
<PackageDescription>1 kg in 1 CARTON (11722-024-00)</PackageDescription>
<NDC11Code>11722-0024-00</NDC11Code>
<ProductNDC>11722-024</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dronedarone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110207</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pliva Hrvatska d.o.o.</LabelerName>
<SubstanceName>DRONEDARONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>