{
"NDC": [
{
"NDCCode": "61755-964-00",
"PackageDescription": "1000 mL in 1 BOTTLE (61755-964-00) ",
"NDC11Code": "61755-0964-00",
"ProductNDC": "61755-964",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Maftivimab",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "MAFTIVIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-18",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-JUL-21"
},
{
"NDCCode": "61755-964-01",
"PackageDescription": "5000 mL in 1 BOTTLE (61755-964-01) ",
"NDC11Code": "61755-0964-01",
"ProductNDC": "61755-964",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Maftivimab",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "MAFTIVIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-18",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-JUL-21"
},
{
"NDCCode": "11673-877-55",
"PackageDescription": "1 KIT in 1 CARTON (11673-877-55) * 1 POWDER, FOR SOLUTION in 1 PACKET (82442-122-00) * 1 POWDER, FOR SOLUTION in 1 PACKET (82442-964-00) ",
"NDC11Code": "11673-0877-55",
"ProductNDC": "11673-877",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Daytime Multi Symptom Severe Cold Nighttime Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20210716",
"EndMarketingDate": "20260801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Target Corporation",
"Status": "Deprecated",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210716",
"EndMarketingDatePackage": "20260801",
"SamplePackage": "N"
},
{
"NDCCode": "55111-964-00",
"PackageDescription": "1 kg in 1 DRUM (55111-964-00)",
"NDC11Code": "55111-0964-00",
"ProductNDC": "55111-964",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140304",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "66267-964-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (66267-964-00) ",
"NDC11Code": "66267-0964-00",
"ProductNDC": "66267-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibu",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "NuCare Pharmaceuticals Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170822",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.",
"Description": "IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide."
},
{
"NDCCode": "71205-964-00",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-00) ",
"NDC11Code": "71205-0964-00",
"ProductNDC": "71205-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203126",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.",
"Description": "Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17H 18N 2O 6, and has the structural formula:. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine GITS (Gastrointestinal Therapeutic System) tablet is formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: cellulose acetate; ferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; potassium chloride; povidone; sodium chloride; titanium dioxide; propylene glycol and black iron oxide. The USP Dissolution Test is pending."
},
{
"NDCCode": "76858-000-00",
"PackageDescription": "964 mL in 1 JUG (76858-000-00) ",
"NDC11Code": "76858-0000-00",
"ProductNDC": "76858-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Stark Spirits LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "82804-964-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (82804-964-00) ",
"NDC11Code": "82804-0964-00",
"ProductNDC": "82804-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078302",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260112",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5-mg and 10-mg tablets are scored so they can be bisected. Thus, the 5-mg tablet can also provide a 2.5-mg dose, and the 10-mg tablet can provide a 5-mg dose. The 15-mg and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A)."
},
{
"NDCCode": "61755-012-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-012-01) / 5 mL in 1 VIAL, SINGLE-DOSE (61755-012-00) ",
"NDC11Code": "61755-0012-01",
"ProductNDC": "61755-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pasatru",
"NonProprietaryName": "Garetosmab-grts",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260819",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761508",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "GARETOSMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260819",
"SamplePackage": "N",
"IndicationAndUsage": "PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).",
"Description": "Garetosmab-grts is an activin signaling inhibitor. Garetosmab-grts is a human IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cell suspension culture. Garetosmab-grts has an approximate molecular weight of 146 kDa. PASATRU (garetosmab-grts) injection is a sterile, preservative-free solution for intravenous use. The solution is clear to slightly opalescent, colorless to pale yellow with a pH of 6.3. Each PASATRU 300 mg/5 mL vial contains 300 mg of garetosmab-grts. Each mL contains 60 mg of garetosmab-grts, arginine hydrochloride (14.7 mg), histidine (1 mg), L-histidine hydrochloride monohydrate (0.7 mg), polysorbate 20 (0.5 mg), sucrose (50 mg), and Water for Injection, USP."
},
{
"NDCCode": "61755-014-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-014-01) / 2 mL in 1 VIAL, SINGLE-DOSE (61755-014-00) ",
"NDC11Code": "61755-0014-01",
"ProductNDC": "61755-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Veopoz",
"NonProprietaryName": "Pozelimab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20230818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761339",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "POZELIMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Complement Inhibitor [EPC], Complement Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "VEOPOZ is indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.",
"Description": "Pozelimab-bbfg, a complement inhibitor, is a recombinant monoclonal antibody (IgG4 isotype). Pozelimab-bbfg is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture and has an approximate molecular weight of 145 kDa. VEOPOZ (pozelimab-bbfg) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution supplied in a single-dose glass vial, free from visible particulates, for intravenous or subcutaneous use. Each vial contains 400 mg pozelimab-bbfg in 2 mL of solution with a pH of 5.8. Each mL contains 200 mg pozelimab-bbfg, arginine hydrochloride (21 mg), histidine (1.15 mg), L-histidine hydrochloride monohydrate (2.65 mg), polysorbate 80 (1.5 mg), sucrose (20 mg), and Water for Injection, USP."
},
{
"NDCCode": "61755-018-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-018-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-018-00) ",
"NDC11Code": "61755-0018-01",
"ProductNDC": "61755-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inmazeb",
"NonProprietaryName": "Atoltivimab, Maftivimab, And Odesivimab-ebgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201014",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761169",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB",
"StrengthNumber": "241.7; 241.7; 241.7",
"StrengthUnit": "mg/14.5mL; mg/14.5mL; mg/14.5mL",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201014",
"SamplePackage": "N",
"IndicationAndUsage": "INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].",
"Description": "Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0."
},
{
"NDCCode": "61755-019-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-019-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-019-00) ",
"NDC11Code": "61755-0019-01",
"ProductNDC": "61755-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inmazeb",
"NonProprietaryName": "Atoltivimab, Maftivimab, And Odesivimab-ebgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761169",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB",
"StrengthNumber": "483.3; 483.3; 483.3",
"StrengthUnit": "mg/14.5mL; mg/14.5mL; mg/14.5mL",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210729",
"SamplePackage": "N",
"IndicationAndUsage": "INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].",
"Description": "Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0."
},
{
"NDCCode": "61755-024-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) ",
"NDC11Code": "61755-0024-01",
"ProductNDC": "61755-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Casirivimab",
"NonProprietaryName": "Casirivimab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201121",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "CASIRIVIMAB",
"StrengthNumber": "1332",
"StrengthUnit": "mg/11.1mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201121",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Imdevimab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
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"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
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"PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) ",
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"ProductNDC": "61755-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Casirivimab",
"NonProprietaryName": "Casirivimab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201121",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
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"StrengthUnit": "mg/2.5mL",
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"LastUpdate": "2025-01-01",
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"StartMarketingDatePackage": "20201121",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
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"PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) ",
"NDC11Code": "61755-0027-01",
"ProductNDC": "61755-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imdevimab",
"NonProprietaryName": "Imdevimab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201121",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
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"StartMarketingDatePackage": "20201121",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
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"PackageDescription": "1 KIT in 1 DOSE PACK (61755-035-02) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) ",
"NDC11Code": "61755-0035-02",
"ProductNDC": "61755-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regen-cov",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
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"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210207",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "61755-036-08",
"PackageDescription": "1 KIT in 1 DOSE PACK (61755-036-08) * 1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) ",
"NDC11Code": "61755-0036-08",
"ProductNDC": "61755-036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regen-cov",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
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"LastUpdate": "2025-01-01",
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"StartMarketingDatePackage": "20210207",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "61755-037-05",
"PackageDescription": "1 KIT in 1 DOSE PACK (61755-037-05) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) ",
"NDC11Code": "61755-0037-05",
"ProductNDC": "61755-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regen-cov",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210207",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "61755-038-05",
"PackageDescription": "1 KIT in 1 DOSE PACK (61755-038-05) * 1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) ",
"NDC11Code": "61755-0038-05",
"ProductNDC": "61755-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regen-cov",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210207",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "61755-039-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-039-01) > 10 mL in 1 VIAL, GLASS (61755-039-00) ",
"NDC11Code": "61755-0039-01",
"ProductNDC": "61755-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regen-cov",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210603",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "CASIRIVIMAB; IMDEVIMAB",
"StrengthNumber": "600; 600",
"StrengthUnit": "mg/10mL; mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210603",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "61755-042-02",
"PackageDescription": "1 KIT in 1 CARTON (61755-042-02) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) ",
"NDC11Code": "61755-0042-02",
"ProductNDC": "61755-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Casirivimab With Imdevimab",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210917",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "61755-045-02",
"PackageDescription": "1 KIT in 1 CARTON (61755-045-02) * 1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) ",
"NDC11Code": "61755-0045-02",
"ProductNDC": "61755-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Casirivimab With Imdevimab",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210917",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "61755-050-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-050-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-050-00) ",
"NDC11Code": "61755-0050-01",
"ProductNDC": "61755-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eylea Hd",
"NonProprietaryName": "Aflibercept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20230818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761355",
"LabelerName": "Regeneron Pharmaceuticals, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "8",
"StrengthUnit": "mg/.07mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "EYLEA HD is indicated for the treatment of.",
"Description": "Aflibercept 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 is a dimeric glycoprotein and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells. EYLEA HD (aflibercept) injection is a sterile, clear to slightly opalescent, and colorless to pale yellow solution. EYLEA HD is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.07 mL (70 microliters) of solution containing 8 mg of aflibercept in a buffer containing arginine hydrochloride (0.737 mg), histidine (0.04 mg), L-histidine hydrochloride monohydrate (0.093 mg), polysorbate 20 (0.021 mg), sucrose (3.5 mg) and water for injection with a pH of 5.8. EYLEA HD does not contain an anti-microbial preservative."
},
{
"NDCCode": "61755-051-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-051-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-051-00) ",
"NDC11Code": "61755-0051-01",
"ProductNDC": "61755-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eylea Hd",
"NonProprietaryName": "Aflibercept",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20230818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761355",
"LabelerName": "Regeneron Pharmaceuticals, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "8",
"StrengthUnit": "mg/.07mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "EYLEA HD is indicated for the treatment of.",
"Description": "Aflibercept 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 is a dimeric glycoprotein and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells. EYLEA HD (aflibercept) injection is a sterile, clear to slightly opalescent, and colorless to pale yellow solution. EYLEA HD is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.07 mL (70 microliters) of solution containing 8 mg of aflibercept in a buffer containing arginine hydrochloride (0.737 mg), histidine (0.04 mg), L-histidine hydrochloride monohydrate (0.093 mg), polysorbate 20 (0.021 mg), sucrose (3.5 mg) and water for injection with a pH of 5.8. EYLEA HD does not contain an anti-microbial preservative."
},
{
"NDCCode": "61755-054-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00) ",
"NDC11Code": "61755-0054-01",
"ProductNDC": "61755-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lynozyfic",
"NonProprietaryName": "Linvoseltamab-gcpt",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250702",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761400",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "LINVOSELTAMAB",
"StrengthNumber": "5",
"StrengthUnit": "mg/2.5mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250702",
"SamplePackage": "N",
"IndicationAndUsage": "LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP."
},
{
"NDCCode": "61755-056-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-056-01) / 10 mL in 1 VIAL, SINGLE-DOSE (61755-056-00) ",
"NDC11Code": "61755-0056-01",
"ProductNDC": "61755-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lynozyfic",
"NonProprietaryName": "Linvoseltamab-gcpt",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250702",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761400",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "LINVOSELTAMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250702",
"SamplePackage": "N",
"IndicationAndUsage": "LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP."
},
{
"NDCCode": "61755-062-99",
"PackageDescription": "1 CARTON in 1 BAG (61755-062-99) / 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-062-01) / 1 mL in 1 VIAL, SINGLE-DOSE (61755-062-00) ",
"NDC11Code": "61755-0062-99",
"ProductNDC": "61755-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Otarmeni",
"NonProprietaryName": "Lunsotogene Parvec-cwha",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACOCHLEAR",
"StartMarketingDate": "20260423",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125874",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "LUNSOTOGENE PARVEC",
"StrengthNumber": "30000000000000",
"StrengthUnit": "{GC}/mL",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260423",
"SamplePackage": "N",
"IndicationAndUsage": "OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. This indication is approved under accelerated approval based on the improvement of hearing sensitivity assessed by average pure tone audiometry (PTA) at Week 24 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory clinical trial. Limitations of Use. OTARMENI is not recommended in patients in whom preoperative imaging demonstrates that access to the inner ear is not feasible including those with abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear and inner ear.",
"Description": "OTARMENI (lunsotogene parvec-cwha) is an adeno-associated virus vector-based gene therapy for intracochlear infusion. OTARMENI contains a dual adeno-associated virus serotype 1 vector (AAV1) that utilizes an engineered hair cell-specific promoter derived from regulatory elements of myosin 15 (Myo15) to drive complementary DNA (cDNA) expression of human OTOF transcript variant 5 encoding isoform e of the otoferlin protein (OTOF). The vector is produced in human embryonic kidney cells by recombinant DNA technology. OTARMENI is a sterile, aqueous suspension administered by intracochlear infusion. Each single-dose vial contains a nominal vector genome titer of 3.0 × 1013 vg/mL in an extractable volume of 0.63 mL. Patients receive a total nominal dose of 7.2 × 1012 vg per ear in a total infused volume of 0.24 mL per ear. OTARMENI is provided in a single-dose 2 mL vial containing a clear to slightly opalescent, colorless suspension, free of visible particulates following thaw from its frozen state. The excipients include sodium phosphate (10 mM), sodium chloride (180 mM), sucrose (5% w/v), and poloxamer 188 (0.001% w/v) with a pH of 7.3."
},
{
"NDCCode": "61755-905-00",
"PackageDescription": "1000 mL in 1 BOTTLE (61755-905-00) ",
"NDC11Code": "61755-0905-00",
"ProductNDC": "61755-905",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Aflibercept",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20111121",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-13",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "21-NOV-11"
},
{
"NDCCode": "61755-908-00",
"PackageDescription": "5000 mL in 1 BOTTLE (61755-908-00) ",
"NDC11Code": "61755-0908-00",
"ProductNDC": "61755-908",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cemiplimab",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "CEMIPLIMAB",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-15",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "28-SEP-18"
}
]
}
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<NDCList>
<NDC>
<NDCCode>61755-964-00</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (61755-964-00) </PackageDescription>
<NDC11Code>61755-0964-00</NDC11Code>
<ProductNDC>61755-964</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Maftivimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MAFTIVIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-18</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-JUL-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61755-964-01</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE (61755-964-01) </PackageDescription>
<NDC11Code>61755-0964-01</NDC11Code>
<ProductNDC>61755-964</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Maftivimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MAFTIVIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-18</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-JUL-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11673-877-55</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (11673-877-55) * 1 POWDER, FOR SOLUTION in 1 PACKET (82442-122-00) * 1 POWDER, FOR SOLUTION in 1 PACKET (82442-964-00) </PackageDescription>
<NDC11Code>11673-0877-55</NDC11Code>
<ProductNDC>11673-877</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Daytime Multi Symptom Severe Cold Nighttime Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210716</StartMarketingDate>
<EndMarketingDate>20260801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210716</StartMarketingDatePackage>
<EndMarketingDatePackage>20260801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-964-00</NDCCode>
<PackageDescription>1 kg in 1 DRUM (55111-964-00)</PackageDescription>
<NDC11Code>55111-0964-00</NDC11Code>
<ProductNDC>55111-964</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dabigatran Etexilate Mesylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140304</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66267-964-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (66267-964-00) </PackageDescription>
<NDC11Code>66267-0964-00</NDC11Code>
<ProductNDC>66267-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibu</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
<Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-964-00</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-00) </PackageDescription>
<NDC11Code>71205-0964-00</NDC11Code>
<ProductNDC>71205-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203126</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
<Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17H 18N 2O 6, and has the structural formula:. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine GITS (Gastrointestinal Therapeutic System) tablet is formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: cellulose acetate; ferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; potassium chloride; povidone; sodium chloride; titanium dioxide; propylene glycol and black iron oxide. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>76858-000-00</NDCCode>
<PackageDescription>964 mL in 1 JUG (76858-000-00) </PackageDescription>
<NDC11Code>76858-0000-00</NDC11Code>
<ProductNDC>76858-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Stark Spirits LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82804-964-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82804-964-00) </PackageDescription>
<NDC11Code>82804-0964-00</NDC11Code>
<ProductNDC>82804-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078302</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5-mg and 10-mg tablets are scored so they can be bisected. Thus, the 5-mg tablet can also provide a 2.5-mg dose, and the 10-mg tablet can provide a 5-mg dose. The 15-mg and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A).</Description>
</NDC>
<NDC>
<NDCCode>61755-012-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-012-01) / 5 mL in 1 VIAL, SINGLE-DOSE (61755-012-00) </PackageDescription>
<NDC11Code>61755-0012-01</NDC11Code>
<ProductNDC>61755-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pasatru</ProprietaryName>
<NonProprietaryName>Garetosmab-grts</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260819</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761508</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GARETOSMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
<Description>Garetosmab-grts is an activin signaling inhibitor. Garetosmab-grts is a human IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cell suspension culture. Garetosmab-grts has an approximate molecular weight of 146 kDa. PASATRU (garetosmab-grts) injection is a sterile, preservative-free solution for intravenous use. The solution is clear to slightly opalescent, colorless to pale yellow with a pH of 6.3. Each PASATRU 300 mg/5 mL vial contains 300 mg of garetosmab-grts. Each mL contains 60 mg of garetosmab-grts, arginine hydrochloride (14.7 mg), histidine (1 mg), L-histidine hydrochloride monohydrate (0.7 mg), polysorbate 20 (0.5 mg), sucrose (50 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>61755-014-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-014-01) / 2 mL in 1 VIAL, SINGLE-DOSE (61755-014-00) </PackageDescription>
<NDC11Code>61755-0014-01</NDC11Code>
<ProductNDC>61755-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Veopoz</ProprietaryName>
<NonProprietaryName>Pozelimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761339</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POZELIMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Complement Inhibitor [EPC], Complement Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VEOPOZ is indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.</IndicationAndUsage>
<Description>Pozelimab-bbfg, a complement inhibitor, is a recombinant monoclonal antibody (IgG4 isotype). Pozelimab-bbfg is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture and has an approximate molecular weight of 145 kDa. VEOPOZ (pozelimab-bbfg) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution supplied in a single-dose glass vial, free from visible particulates, for intravenous or subcutaneous use. Each vial contains 400 mg pozelimab-bbfg in 2 mL of solution with a pH of 5.8. Each mL contains 200 mg pozelimab-bbfg, arginine hydrochloride (21 mg), histidine (1.15 mg), L-histidine hydrochloride monohydrate (2.65 mg), polysorbate 80 (1.5 mg), sucrose (20 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>61755-018-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-018-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-018-00) </PackageDescription>
<NDC11Code>61755-0018-01</NDC11Code>
<ProductNDC>61755-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inmazeb</ProprietaryName>
<NonProprietaryName>Atoltivimab, Maftivimab, And Odesivimab-ebgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201014</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761169</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB</SubstanceName>
<StrengthNumber>241.7; 241.7; 241.7</StrengthNumber>
<StrengthUnit>mg/14.5mL; mg/14.5mL; mg/14.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].</IndicationAndUsage>
<Description>Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-019-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-019-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-019-00) </PackageDescription>
<NDC11Code>61755-0019-01</NDC11Code>
<ProductNDC>61755-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inmazeb</ProprietaryName>
<NonProprietaryName>Atoltivimab, Maftivimab, And Odesivimab-ebgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761169</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB</SubstanceName>
<StrengthNumber>483.3; 483.3; 483.3</StrengthNumber>
<StrengthUnit>mg/14.5mL; mg/14.5mL; mg/14.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].</IndicationAndUsage>
<Description>Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-024-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) </PackageDescription>
<NDC11Code>61755-0024-01</NDC11Code>
<ProductNDC>61755-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Casirivimab</ProprietaryName>
<NonProprietaryName>Casirivimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201121</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CASIRIVIMAB</SubstanceName>
<StrengthNumber>1332</StrengthNumber>
<StrengthUnit>mg/11.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-025-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) </PackageDescription>
<NDC11Code>61755-0025-01</NDC11Code>
<ProductNDC>61755-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imdevimab</ProprietaryName>
<NonProprietaryName>Imdevimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201121</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>IMDEVIMAB</SubstanceName>
<StrengthNumber>1332</StrengthNumber>
<StrengthUnit>mg/11.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-026-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) </PackageDescription>
<NDC11Code>61755-0026-01</NDC11Code>
<ProductNDC>61755-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Casirivimab</ProprietaryName>
<NonProprietaryName>Casirivimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201121</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CASIRIVIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-027-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) </PackageDescription>
<NDC11Code>61755-0027-01</NDC11Code>
<ProductNDC>61755-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imdevimab</ProprietaryName>
<NonProprietaryName>Imdevimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201121</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>IMDEVIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-035-02</NDCCode>
<PackageDescription>1 KIT in 1 DOSE PACK (61755-035-02) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) </PackageDescription>
<NDC11Code>61755-0035-02</NDC11Code>
<ProductNDC>61755-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regen-cov</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-036-08</NDCCode>
<PackageDescription>1 KIT in 1 DOSE PACK (61755-036-08) * 1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) </PackageDescription>
<NDC11Code>61755-0036-08</NDC11Code>
<ProductNDC>61755-036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regen-cov</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-037-05</NDCCode>
<PackageDescription>1 KIT in 1 DOSE PACK (61755-037-05) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) </PackageDescription>
<NDC11Code>61755-0037-05</NDC11Code>
<ProductNDC>61755-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regen-cov</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-038-05</NDCCode>
<PackageDescription>1 KIT in 1 DOSE PACK (61755-038-05) * 1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) </PackageDescription>
<NDC11Code>61755-0038-05</NDC11Code>
<ProductNDC>61755-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regen-cov</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-039-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (61755-039-01) > 10 mL in 1 VIAL, GLASS (61755-039-00) </PackageDescription>
<NDC11Code>61755-0039-01</NDC11Code>
<ProductNDC>61755-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regen-cov</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CASIRIVIMAB; IMDEVIMAB</SubstanceName>
<StrengthNumber>600; 600</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-042-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (61755-042-02) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) </PackageDescription>
<NDC11Code>61755-0042-02</NDC11Code>
<ProductNDC>61755-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Casirivimab With Imdevimab</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-045-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (61755-045-02) * 1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) </PackageDescription>
<NDC11Code>61755-0045-02</NDC11Code>
<ProductNDC>61755-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Casirivimab With Imdevimab</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-050-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-050-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-050-00) </PackageDescription>
<NDC11Code>61755-0050-01</NDC11Code>
<ProductNDC>61755-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eylea Hd</ProprietaryName>
<NonProprietaryName>Aflibercept</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20230818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761355</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/.07mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EYLEA HD is indicated for the treatment of.</IndicationAndUsage>
<Description>Aflibercept 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 is a dimeric glycoprotein and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells. EYLEA HD (aflibercept) injection is a sterile, clear to slightly opalescent, and colorless to pale yellow solution. EYLEA HD is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.07 mL (70 microliters) of solution containing 8 mg of aflibercept in a buffer containing arginine hydrochloride (0.737 mg), histidine (0.04 mg), L-histidine hydrochloride monohydrate (0.093 mg), polysorbate 20 (0.021 mg), sucrose (3.5 mg) and water for injection with a pH of 5.8. EYLEA HD does not contain an anti-microbial preservative.</Description>
</NDC>
<NDC>
<NDCCode>61755-051-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-051-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-051-00) </PackageDescription>
<NDC11Code>61755-0051-01</NDC11Code>
<ProductNDC>61755-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eylea Hd</ProprietaryName>
<NonProprietaryName>Aflibercept</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20230818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761355</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/.07mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EYLEA HD is indicated for the treatment of.</IndicationAndUsage>
<Description>Aflibercept 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 is a dimeric glycoprotein and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells. EYLEA HD (aflibercept) injection is a sterile, clear to slightly opalescent, and colorless to pale yellow solution. EYLEA HD is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.07 mL (70 microliters) of solution containing 8 mg of aflibercept in a buffer containing arginine hydrochloride (0.737 mg), histidine (0.04 mg), L-histidine hydrochloride monohydrate (0.093 mg), polysorbate 20 (0.021 mg), sucrose (3.5 mg) and water for injection with a pH of 5.8. EYLEA HD does not contain an anti-microbial preservative.</Description>
</NDC>
<NDC>
<NDCCode>61755-054-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00) </PackageDescription>
<NDC11Code>61755-0054-01</NDC11Code>
<ProductNDC>61755-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lynozyfic</ProprietaryName>
<NonProprietaryName>Linvoseltamab-gcpt</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250702</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761400</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINVOSELTAMAB</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>61755-056-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-056-01) / 10 mL in 1 VIAL, SINGLE-DOSE (61755-056-00) </PackageDescription>
<NDC11Code>61755-0056-01</NDC11Code>
<ProductNDC>61755-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lynozyfic</ProprietaryName>
<NonProprietaryName>Linvoseltamab-gcpt</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250702</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761400</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINVOSELTAMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>61755-062-99</NDCCode>
<PackageDescription>1 CARTON in 1 BAG (61755-062-99) / 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-062-01) / 1 mL in 1 VIAL, SINGLE-DOSE (61755-062-00) </PackageDescription>
<NDC11Code>61755-0062-99</NDC11Code>
<ProductNDC>61755-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Otarmeni</ProprietaryName>
<NonProprietaryName>Lunsotogene Parvec-cwha</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACOCHLEAR</RouteName>
<StartMarketingDate>20260423</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125874</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LUNSOTOGENE PARVEC</SubstanceName>
<StrengthNumber>30000000000000</StrengthNumber>
<StrengthUnit>{GC}/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. This indication is approved under accelerated approval based on the improvement of hearing sensitivity assessed by average pure tone audiometry (PTA) at Week 24 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory clinical trial. Limitations of Use. OTARMENI is not recommended in patients in whom preoperative imaging demonstrates that access to the inner ear is not feasible including those with abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear and inner ear.</IndicationAndUsage>
<Description>OTARMENI (lunsotogene parvec-cwha) is an adeno-associated virus vector-based gene therapy for intracochlear infusion. OTARMENI contains a dual adeno-associated virus serotype 1 vector (AAV1) that utilizes an engineered hair cell-specific promoter derived from regulatory elements of myosin 15 (Myo15) to drive complementary DNA (cDNA) expression of human OTOF transcript variant 5 encoding isoform e of the otoferlin protein (OTOF). The vector is produced in human embryonic kidney cells by recombinant DNA technology. OTARMENI is a sterile, aqueous suspension administered by intracochlear infusion. Each single-dose vial contains a nominal vector genome titer of 3.0 × 1013 vg/mL in an extractable volume of 0.63 mL. Patients receive a total nominal dose of 7.2 × 1012 vg per ear in a total infused volume of 0.24 mL per ear. OTARMENI is provided in a single-dose 2 mL vial containing a clear to slightly opalescent, colorless suspension, free of visible particulates following thaw from its frozen state. The excipients include sodium phosphate (10 mM), sodium chloride (180 mM), sucrose (5% w/v), and poloxamer 188 (0.001% w/v) with a pH of 7.3.</Description>
</NDC>
<NDC>
<NDCCode>61755-905-00</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (61755-905-00) </PackageDescription>
<NDC11Code>61755-0905-00</NDC11Code>
<ProductNDC>61755-905</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Aflibercept</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20111121</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-13</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-NOV-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61755-908-00</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE (61755-908-00) </PackageDescription>
<NDC11Code>61755-0908-00</NDC11Code>
<ProductNDC>61755-908</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cemiplimab</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20180928</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEMIPLIMAB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-15</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-SEP-18</StartMarketingDatePackage>
</NDC>
</NDCList>