{
"NDC": [
{
"NDCCode": "55513-056-96",
"PackageDescription": "1 SYRINGE in 1 CARTON (55513-056-96) / .05 mL in 1 SYRINGE",
"NDC11Code": "55513-0056-96",
"ProductNDC": "55513-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pavblu",
"NonProprietaryName": "Aflibercept-ayyh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761298",
"LabelerName": "Amgen, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "2",
"StrengthUnit": "mg/.05mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "PAVBLU is indicated for the treatment of.",
"Description": "Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2."
},
{
"NDCCode": "55513-056-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (55513-056-01) / .05 mL in 1 SYRINGE",
"NDC11Code": "55513-0056-01",
"ProductNDC": "55513-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pavblu",
"NonProprietaryName": "Aflibercept-ayyh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761298",
"LabelerName": "Amgen, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "2",
"StrengthUnit": "mg/.05mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "PAVBLU is indicated for the treatment of.",
"Description": "Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2."
},
{
"NDCCode": "84126-056-96",
"PackageDescription": "96 g in 1 CYLINDER (84126-056-96) ",
"NDC11Code": "84126-0056-96",
"ProductNDC": "84126-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Outlast Unscented Clear",
"NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
"StrengthNumber": "16",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240201",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "55513-065-96",
"PackageDescription": "1 VIAL in 1 CARTON (55513-065-96) / .05 mL in 1 VIAL",
"NDC11Code": "55513-0065-96",
"ProductNDC": "55513-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pavblu",
"NonProprietaryName": "Aflibercept-ayyh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761298",
"LabelerName": "Amgen, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "2",
"StrengthUnit": "mg/.05mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "PAVBLU is indicated for the treatment of.",
"Description": "Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2."
},
{
"NDCCode": "55513-100-96",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (55513-100-96) / 1.91 mL in 1 VIAL, GLASS",
"NDC11Code": "55513-0100-96",
"ProductNDC": "55513-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tezspire",
"NonProprietaryName": "Tezepelumab-ekko",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211217",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761224",
"LabelerName": "Amgen, Inc",
"SubstanceName": "TEZEPELUMAB",
"StrengthNumber": "210",
"StrengthUnit": "mg/1.9mL",
"Pharm_Classes": "Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211217",
"SamplePackage": "Y",
"IndicationAndUsage": "TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.",
"Description": "Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2."
},
{
"NDCCode": "55513-112-96",
"PackageDescription": "1 SYRINGE in 1 CARTON (55513-112-96) / 1.91 mL in 1 SYRINGE",
"NDC11Code": "55513-0112-96",
"ProductNDC": "55513-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tezspire",
"NonProprietaryName": "Tezepelumab-ekko",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211217",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761224",
"LabelerName": "Amgen Inc",
"SubstanceName": "TEZEPELUMAB",
"StrengthNumber": "210",
"StrengthUnit": "mg/1.9mL",
"Pharm_Classes": "Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211217",
"SamplePackage": "Y",
"IndicationAndUsage": "TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: : 1 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. (1.1), 2 Limitations of Use:, 3 Not for relief of acute bronchospasm or status asthmaticus. (1.1), 4 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2).",
"Description": "Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2."
},
{
"NDCCode": "55513-123-96",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (55513-123-96) / 1.91 mL in 1 CARTRIDGE",
"NDC11Code": "55513-0123-96",
"ProductNDC": "55513-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tezspire",
"NonProprietaryName": "Tezepelumab-ekko",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211217",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761224",
"LabelerName": "Amgen Inc",
"SubstanceName": "TEZEPELUMAB",
"StrengthNumber": "210",
"StrengthUnit": "mg/1.9mL",
"Pharm_Classes": "Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240220",
"SamplePackage": "Y",
"IndicationAndUsage": "TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: : 1 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. (1.1), 2 Limitations of Use:, 3 Not for relief of acute bronchospasm or status asthmaticus. (1.1), 4 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2).",
"Description": "Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2."
},
{
"NDCCode": "55513-485-96",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (55513-485-96) / 1 KIT in 1 BLISTER PACK (55513-485-95) ",
"NDC11Code": "55513-0485-96",
"ProductNDC": "55513-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Otezla",
"NonProprietaryName": "Apremilast",
"DosageFormName": "KIT",
"StartMarketingDate": "20200226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205437",
"LabelerName": "Amgen, Inc",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200226",
"SamplePackage": "N",
"IndicationAndUsage": "OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of. Adult patients with: 1 Active psoriatic arthritis (1.1), 2 Plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2), 3 Oral ulcers associated with Behçet's Disease (1.3).",
"Description": "The active ingredient in OTEZLA/OTEZLA XR tablets is apremilast. Apremilast drug substance is non-hygroscopic. Apremilast drug substance is practically insoluble in water and slightly soluble in alcohol. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C22H24N2O7S and the molecular weight is 460.5. The chemical structure is. OTEZLA (apremilast) tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. OTEZLA XR (apremilast) extended-release tablets are supplied in a 75 mg strength for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hydroxypropyl methylcellulose acetate succinate, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, titanium dioxide."
},
{
"NDCCode": "55513-488-96",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55513-0488-96",
"ProductNDC": "55513-488",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "Y",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "55513-996-95",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (55513-996-95) / 1 KIT in 1 BLISTER PACK (55513-996-96) * 4 TABLET, FILM COATED in 1 BLISTER PACK (55513-518-04) * 23 TABLET, FILM COATED in 1 BLISTER PACK (55513-497-23) ",
"NDC11Code": "55513-0996-95",
"ProductNDC": "55513-996",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Otezla",
"NonProprietaryName": "Apremilast",
"DosageFormName": "KIT",
"StartMarketingDate": "20240425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205437",
"LabelerName": "Amgen, Inc",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240427",
"SamplePackage": "N",
"IndicationAndUsage": "OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of. Adult patients with: 1 Active psoriatic arthritis (1.1), 2 Plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2), 3 Oral ulcers associated with Behçet's Disease (1.3).",
"Description": "The active ingredient in OTEZLA/OTEZLA XR tablets is apremilast. Apremilast drug substance is non-hygroscopic. Apremilast drug substance is practically insoluble in water and slightly soluble in alcohol. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C22H24N2O7S and the molecular weight is 460.5. The chemical structure is. OTEZLA (apremilast) tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. OTEZLA XR (apremilast) extended-release tablets are supplied in a 75 mg strength for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hydroxypropyl methylcellulose acetate succinate, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, titanium dioxide."
},
{
"NDCCode": "65038-056-01",
"PackageDescription": "1 PATCH in 1 POUCH (65038-056-01) ",
"NDC11Code": "65038-0056-01",
"ProductNDC": "65038-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlarity",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212304",
"LabelerName": "Corium, LLC.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220907",
"SamplePackage": "N",
"IndicationAndUsage": "ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.",
"Description": "ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin."
},
{
"NDCCode": "65038-056-03",
"PackageDescription": "4 POUCH in 1 CARTON (65038-056-03) / 1 PATCH in 1 POUCH (65038-056-01) ",
"NDC11Code": "65038-0056-03",
"ProductNDC": "65038-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlarity",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212304",
"LabelerName": "Corium, LLC.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220311",
"SamplePackage": "N",
"IndicationAndUsage": "ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.",
"Description": "ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin."
},
{
"NDCCode": "65038-056-04",
"PackageDescription": "1 POUCH in 1 CARTON (65038-056-04) / 1 PATCH in 1 POUCH (65038-056-10) ",
"NDC11Code": "65038-0056-04",
"ProductNDC": "65038-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlarity",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212304",
"LabelerName": "Corium, LLC.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220311",
"SamplePackage": "Y",
"IndicationAndUsage": "ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.",
"Description": "ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin."
},
{
"NDCCode": "65038-056-10",
"PackageDescription": "1 PATCH in 1 POUCH (65038-056-10) ",
"NDC11Code": "65038-0056-10",
"ProductNDC": "65038-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlarity",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20220311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212304",
"LabelerName": "Corium, LLC.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220907",
"SamplePackage": "Y",
"IndicationAndUsage": "ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.",
"Description": "ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin."
},
{
"NDCCode": "55513-002-04",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-002-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-002-01) ",
"NDC11Code": "55513-0002-04",
"ProductNDC": "55513-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060911",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "25",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060911",
"SamplePackage": "N",
"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-003-04",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01) ",
"NDC11Code": "55513-0003-04",
"ProductNDC": "55513-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060911",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "40",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060911",
"SamplePackage": "N",
"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-004-04",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-004-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-004-01) ",
"NDC11Code": "55513-0004-04",
"ProductNDC": "55513-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060911",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "60",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060911",
"SamplePackage": "N",
"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-005-04",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-005-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-005-01) ",
"NDC11Code": "55513-0005-04",
"ProductNDC": "55513-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060911",
"SamplePackage": "N",
"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-006-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55513-0006-01",
"ProductNDC": "55513-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060911",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "200",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060911",
"SamplePackage": "N",
"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-006-21",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-21) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55513-0006-21",
"ProductNDC": "55513-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060911",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "200",
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"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-021-04",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE (55513-021-04) / 4 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE (55513-021-01) ",
"NDC11Code": "55513-0021-04",
"ProductNDC": "55513-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "40",
"StrengthUnit": "ug/.4mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-023-04",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE (55513-023-04) / 4 SYRINGE in 1 BLISTER PACK / .3 mL in 1 SYRINGE (55513-023-01) ",
"NDC11Code": "55513-0023-04",
"ProductNDC": "55513-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
"SubstanceName": "DARBEPOETIN ALFA",
"StrengthNumber": "60",
"StrengthUnit": "ug/.3mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": "Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).",
"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-025-04",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE (55513-025-04) / 4 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE (55513-025-01) ",
"NDC11Code": "55513-0025-04",
"ProductNDC": "55513-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
"NonProprietaryName": "Darbepoetin Alfa",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103951",
"LabelerName": "Amgen, Inc",
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"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
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"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
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"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
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"ProductNDC": "55513-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aranesp",
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"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
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{
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"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
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"Description": "Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2)."
},
{
"NDCCode": "55513-059-01",
"PackageDescription": "1 KIT in 1 PACKAGE (55513-059-01) * 1 mg in 1 VIAL (55513-103-01) * 7 mL in 1 VIAL (55513-068-01) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.",
"Description": "Tarlatamab-dlle is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle is produced using recombinant DNA technology in Chinese hamster ovary cells. It consists of 982 amino acids and has a molecular weight of approximately 105 kilodaltons. IMDELLTRA (tarlatamab-dlle) for injection is supplied as a sterile, preservative-free, white to slightly yellow, lyophilized powder in a single-dose vial for reconstitution and further dilution. Each 1 mg vial contains tarlatamab-dlle (1 mg), glutamic acid (0.72 mg), polysorbate 80 (0.04 mg), sucrose (37.1 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 1.3 mL of Sterile Water for Injection the resulting concentration is 0.9 mg/mL IMDELLTRA. Each 10 mg vial contains tarlatamab-dlle (10 mg), glutamic acid (3.7 mg), polysorbate 80 (0.2 mg), sucrose (194.4 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 4.4 mL of Sterile Water for Injection the resulting concentration is 2.4 mg/mL IMDELLTRA. IV Solution Stabilizer is supplied as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each vial of IV Solution Stabilizer contains citric acid monohydrate (36.75 mg), lysine hydrochloride (1598.8 mg), polysorbate 80 (7 mg), sodium hydroxide to adjust pH to 7.0, and water for injection."
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{
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tezspire</ProprietaryName>
<NonProprietaryName>Tezepelumab-ekko</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211217</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761224</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>TEZEPELUMAB</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mg/1.9mL</StrengthUnit>
<Pharm_Classes>Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211217</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.</IndicationAndUsage>
<Description>Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-112-96</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (55513-112-96) / 1.91 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>55513-0112-96</NDC11Code>
<ProductNDC>55513-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tezspire</ProprietaryName>
<NonProprietaryName>Tezepelumab-ekko</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211217</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761224</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>TEZEPELUMAB</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mg/1.9mL</StrengthUnit>
<Pharm_Classes>Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211217</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: : 1 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. (1.1), 2 Limitations of Use:, 3 Not for relief of acute bronchospasm or status asthmaticus. (1.1), 4 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2).</IndicationAndUsage>
<Description>Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-123-96</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (55513-123-96) / 1.91 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>55513-0123-96</NDC11Code>
<ProductNDC>55513-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tezspire</ProprietaryName>
<NonProprietaryName>Tezepelumab-ekko</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211217</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761224</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>TEZEPELUMAB</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mg/1.9mL</StrengthUnit>
<Pharm_Classes>Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240220</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: : 1 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. (1.1), 2 Limitations of Use:, 3 Not for relief of acute bronchospasm or status asthmaticus. (1.1), 4 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2).</IndicationAndUsage>
<Description>Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-485-96</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (55513-485-96) / 1 KIT in 1 BLISTER PACK (55513-485-95) </PackageDescription>
<NDC11Code>55513-0485-96</NDC11Code>
<ProductNDC>55513-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Otezla</ProprietaryName>
<NonProprietaryName>Apremilast</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205437</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of. Adult patients with: 1 Active psoriatic arthritis (1.1), 2 Plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2), 3 Oral ulcers associated with Behçet's Disease (1.3).</IndicationAndUsage>
<Description>The active ingredient in OTEZLA/OTEZLA XR tablets is apremilast. Apremilast drug substance is non-hygroscopic. Apremilast drug substance is practically insoluble in water and slightly soluble in alcohol. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C22H24N2O7S and the molecular weight is 460.5. The chemical structure is. OTEZLA (apremilast) tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. OTEZLA XR (apremilast) extended-release tablets are supplied in a 75 mg strength for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hydroxypropyl methylcellulose acetate succinate, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55513-488-96</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55513-0488-96</NDC11Code>
<ProductNDC>55513-488</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>55513-996-95</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (55513-996-95) / 1 KIT in 1 BLISTER PACK (55513-996-96) * 4 TABLET, FILM COATED in 1 BLISTER PACK (55513-518-04) * 23 TABLET, FILM COATED in 1 BLISTER PACK (55513-497-23) </PackageDescription>
<NDC11Code>55513-0996-95</NDC11Code>
<ProductNDC>55513-996</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Otezla</ProprietaryName>
<NonProprietaryName>Apremilast</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205437</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of. Adult patients with: 1 Active psoriatic arthritis (1.1), 2 Plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2), 3 Oral ulcers associated with Behçet's Disease (1.3).</IndicationAndUsage>
<Description>The active ingredient in OTEZLA/OTEZLA XR tablets is apremilast. Apremilast drug substance is non-hygroscopic. Apremilast drug substance is practically insoluble in water and slightly soluble in alcohol. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C22H24N2O7S and the molecular weight is 460.5. The chemical structure is. OTEZLA (apremilast) tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. OTEZLA XR (apremilast) extended-release tablets are supplied in a 75 mg strength for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hydroxypropyl methylcellulose acetate succinate, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65038-056-01</NDCCode>
<PackageDescription>1 PATCH in 1 POUCH (65038-056-01) </PackageDescription>
<NDC11Code>65038-0056-01</NDC11Code>
<ProductNDC>65038-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlarity</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212304</ApplicationNumber>
<LabelerName>Corium, LLC.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin.</Description>
</NDC>
<NDC>
<NDCCode>65038-056-03</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (65038-056-03) / 1 PATCH in 1 POUCH (65038-056-01) </PackageDescription>
<NDC11Code>65038-0056-03</NDC11Code>
<ProductNDC>65038-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlarity</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212304</ApplicationNumber>
<LabelerName>Corium, LLC.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin.</Description>
</NDC>
<NDC>
<NDCCode>65038-056-04</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (65038-056-04) / 1 PATCH in 1 POUCH (65038-056-10) </PackageDescription>
<NDC11Code>65038-0056-04</NDC11Code>
<ProductNDC>65038-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlarity</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212304</ApplicationNumber>
<LabelerName>Corium, LLC.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220311</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin.</Description>
</NDC>
<NDC>
<NDCCode>65038-056-10</NDCCode>
<PackageDescription>1 PATCH in 1 POUCH (65038-056-10) </PackageDescription>
<NDC11Code>65038-0056-10</NDC11Code>
<ProductNDC>65038-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlarity</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20220311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212304</ApplicationNumber>
<LabelerName>Corium, LLC.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220907</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>ADLARITY (donepezil transdermal system) contains donepezil hydrocholoride, which is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenyl-methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3·HCl and a molecular weight of 415.96 g/mol. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ADLARITY is for transdermal administration of donepezil over a 7-day period. The transdermal system is a rectangular 6-layer laminate containing a tan colored overlay backing/adhesive layer without donepezil, separating layer, drug matrix, membrane, contact adhesive, and a release liner. Figure 1: Cross Section of ADLARITY. The ADLARITY transdermal system is available in two strengths (5 mg donepezil/day and 10 mg donepezil/day). Each system contains donepezil 88.4 mg or 176.7 mg donepezil, respectively, present as donepezil (15% to 35%) and donepezil HCl (65% to 85%). The inactive ingredients include acrylate copolymer, ascorbyl palmitate, crospovidone, glycerol, lauryl lactate, polypropylene membrane, sodium bicarbonate, sorbitan monolaurate, and triethyl citrate. The transdermal system contains a mixture of donepezil hydrochloride and donepezil base that delivers donepezil base to permeate the skin.</Description>
</NDC>
<NDC>
<NDCCode>55513-002-04</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-002-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-002-01) </PackageDescription>
<NDC11Code>55513-0002-04</NDC11Code>
<ProductNDC>55513-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-003-04</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-003-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-003-01) </PackageDescription>
<NDC11Code>55513-0003-04</NDC11Code>
<ProductNDC>55513-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-004-04</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-004-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-004-01) </PackageDescription>
<NDC11Code>55513-0004-04</NDC11Code>
<ProductNDC>55513-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-005-04</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-005-04) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-005-01) </PackageDescription>
<NDC11Code>55513-0005-04</NDC11Code>
<ProductNDC>55513-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-006-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55513-0006-01</NDC11Code>
<ProductNDC>55513-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-006-21</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-006-21) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55513-0006-21</NDC11Code>
<ProductNDC>55513-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-021-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-021-04) / 4 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE (55513-021-01) </PackageDescription>
<NDC11Code>55513-0021-04</NDC11Code>
<ProductNDC>55513-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/.4mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-023-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-023-04) / 4 SYRINGE in 1 BLISTER PACK / .3 mL in 1 SYRINGE (55513-023-01) </PackageDescription>
<NDC11Code>55513-0023-04</NDC11Code>
<ProductNDC>55513-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>ug/.3mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-025-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-025-04) / 4 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE (55513-025-01) </PackageDescription>
<NDC11Code>55513-0025-04</NDC11Code>
<ProductNDC>55513-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-027-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-027-04) / 4 SYRINGE in 1 BLISTER PACK / .3 mL in 1 SYRINGE (55513-027-01) </PackageDescription>
<NDC11Code>55513-0027-04</NDC11Code>
<ProductNDC>55513-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/.3mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-028-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-028-01) / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>55513-0028-01</NDC11Code>
<ProductNDC>55513-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/.4mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-032-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-032-01) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>55513-0032-01</NDC11Code>
<ProductNDC>55513-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060607</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-053-04</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 PACKAGE (55513-053-04) > .75 mL in 1 VIAL, SINGLE-DOSE (55513-053-01) </PackageDescription>
<NDC11Code>55513-0053-04</NDC11Code>
<ProductNDC>55513-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/.75mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55513-057-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55513-057-04) / 4 SYRINGE in 1 BLISTER PACK / .42 mL in 1 SYRINGE (55513-057-01) </PackageDescription>
<NDC11Code>55513-0057-04</NDC11Code>
<ProductNDC>55513-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aranesp</ProprietaryName>
<NonProprietaryName>Darbepoetin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060826</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103951</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>DARBEPOETIN ALFA</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/.42mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: 1 Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1)., 2 The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).</IndicationAndUsage>
<Description>Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Aranesp (darbepoetin alfa) injection is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 ± 0.2).</Description>
</NDC>
<NDC>
<NDCCode>55513-059-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (55513-059-01) * 1 mg in 1 VIAL (55513-103-01) * 7 mL in 1 VIAL (55513-068-01) </PackageDescription>
<NDC11Code>55513-0059-01</NDC11Code>
<ProductNDC>55513-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imdelltra (amg757)</ProprietaryName>
<NonProprietaryName>Tarlatamab-dlle</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240516</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761344</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.</IndicationAndUsage>
<Description>Tarlatamab-dlle is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle is produced using recombinant DNA technology in Chinese hamster ovary cells. It consists of 982 amino acids and has a molecular weight of approximately 105 kilodaltons. IMDELLTRA (tarlatamab-dlle) for injection is supplied as a sterile, preservative-free, white to slightly yellow, lyophilized powder in a single-dose vial for reconstitution and further dilution. Each 1 mg vial contains tarlatamab-dlle (1 mg), glutamic acid (0.72 mg), polysorbate 80 (0.04 mg), sucrose (37.1 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 1.3 mL of Sterile Water for Injection the resulting concentration is 0.9 mg/mL IMDELLTRA. Each 10 mg vial contains tarlatamab-dlle (10 mg), glutamic acid (3.7 mg), polysorbate 80 (0.2 mg), sucrose (194.4 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 4.4 mL of Sterile Water for Injection the resulting concentration is 2.4 mg/mL IMDELLTRA. IV Solution Stabilizer is supplied as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each vial of IV Solution Stabilizer contains citric acid monohydrate (36.75 mg), lysine hydrochloride (1598.8 mg), polysorbate 80 (7 mg), sodium hydroxide to adjust pH to 7.0, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>55513-065-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (55513-065-01) / .05 mL in 1 VIAL</PackageDescription>
<NDC11Code>55513-0065-01</NDC11Code>
<ProductNDC>55513-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pavblu</ProprietaryName>
<NonProprietaryName>Aflibercept-ayyh</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761298</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PAVBLU is indicated for the treatment of.</IndicationAndUsage>
<Description>Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2.</Description>
</NDC>
</NDCList>