{
"NDC": [
{
"NDCCode": "61755-930-00",
"PackageDescription": "1000 mL in 1 BOTTLE (61755-930-00) ",
"NDC11Code": "61755-0930-00",
"ProductNDC": "61755-930",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Aflibercept",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20120803",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-15",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "03-AUG-12"
},
{
"NDCCode": "49035-930-19",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (49035-930-19) / 237 mL in 1 BOTTLE, PLASTIC (49035-930-00) ",
"NDC11Code": "49035-0930-19",
"ProductNDC": "49035-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Dm Max",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180815",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."
},
{
"NDCCode": "52544-930-00",
"PackageDescription": "11185 CAPSULE in 1 BOX (52544-930-00) ",
"NDC11Code": "52544-0930-00",
"ProductNDC": "52544-930",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ursodiol",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "19871231",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "URSODIOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "31-DEC-87",
"EndMarketingDatePackage": "31-OCT-23"
},
{
"NDCCode": "55700-930-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (55700-930-00) ",
"NDC11Code": "55700-0930-00",
"ProductNDC": "55700-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laxacin",
"NonProprietaryName": "Docusate Sodium And Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210910",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES A AND B",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210910",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves occasional constipation (irregularity), 2 generally produces a bowel movement in 6-12 hours."
},
{
"NDCCode": "62207-930-00",
"PackageDescription": "1 BAG in 1 DRUM (62207-930-00) / 5 kg in 1 BAG",
"NDC11Code": "62207-0930-00",
"ProductNDC": "62207-930",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Paracetamol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20200612",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Granules India Limited",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "12-JUN-20"
},
{
"NDCCode": "63323-930-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-930-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-930-00) ",
"NDC11Code": "63323-0930-01",
"ProductNDC": "63323-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213206",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "VASOPRESSIN",
"StrengthNumber": "20",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230526",
"SamplePackage": "N",
"IndicationAndUsage": "Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are included to adjust to a pH of 3.8. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl- L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:."
},
{
"NDCCode": "71205-930-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (71205-930-00) ",
"NDC11Code": "71205-0930-00",
"ProductNDC": "71205-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204989",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210422",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
"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."
},
{
"NDCCode": "61755-025-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-025-01) > 11.1 mL in 1 VIAL, GLASS (61755-025-00) ",
"NDC11Code": "61755-0025-01",
"ProductNDC": "61755-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imdevimab",
"NonProprietaryName": "Imdevimab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201121",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "IMDEVIMAB",
"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."
},
{
"NDCCode": "61755-026-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (61755-026-01) > 2.5 mL in 1 VIAL, GLASS (61755-026-00) ",
"NDC11Code": "61755-0026-01",
"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.",
"SubstanceName": "CASIRIVIMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2.5mL",
"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."
},
{
"NDCCode": "61755-027-01",
"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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"StrengthNumber": "300",
"StrengthUnit": "mg/2.5mL",
"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."
},
{
"NDCCode": "61755-035-02",
"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",
"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": "61755-036-08",
"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.",
"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": "61755-037-05",
"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",
"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": "61755-038-05",
"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"
},
{
"NDCCode": "61755-909-00",
"PackageDescription": "5000 mL in 1 BOTTLE (61755-909-00) ",
"NDC11Code": "61755-0909-00",
"ProductNDC": "61755-909",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cemiplimab",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "CEMIPLIMAB",
"StrengthNumber": "175",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-15",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "28-SEP-18"
}
]
}
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<NDCList>
<NDC>
<NDCCode>61755-930-00</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (61755-930-00) </PackageDescription>
<NDC11Code>61755-0930-00</NDC11Code>
<ProductNDC>61755-930</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Aflibercept</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20120803</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-15</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-AUG-12</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49035-930-19</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (49035-930-19) / 237 mL in 1 BOTTLE, PLASTIC (49035-930-00) </PackageDescription>
<NDC11Code>49035-0930-19</NDC11Code>
<ProductNDC>49035-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Dm Max</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52544-930-00</NDCCode>
<PackageDescription>11185 CAPSULE in 1 BOX (52544-930-00) </PackageDescription>
<NDC11Code>52544-0930-00</NDC11Code>
<ProductNDC>52544-930</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ursodiol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>19871231</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>31-DEC-87</StartMarketingDatePackage>
<EndMarketingDatePackage>31-OCT-23</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55700-930-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (55700-930-00) </PackageDescription>
<NDC11Code>55700-0930-00</NDC11Code>
<ProductNDC>55700-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laxacin</ProprietaryName>
<NonProprietaryName>Docusate Sodium And Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210910</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES A AND B</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210910</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 relieves occasional constipation (irregularity), 2 generally produces a bowel movement in 6-12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62207-930-00</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (62207-930-00) / 5 kg in 1 BAG</PackageDescription>
<NDC11Code>62207-0930-00</NDC11Code>
<ProductNDC>62207-930</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Paracetamol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20200612</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Granules India Limited</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-JUN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63323-930-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-930-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-930-00) </PackageDescription>
<NDC11Code>63323-0930-01</NDC11Code>
<ProductNDC>63323-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213206</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are included to adjust to a pH of 3.8. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl- L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>71205-930-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (71205-930-00) </PackageDescription>
<NDC11Code>71205-0930-00</NDC11Code>
<ProductNDC>71205-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204989</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</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>
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