{
"NDC": [
{
"NDCCode": "83257-019-32",
"PackageDescription": "2 TRAY in 1 KIT (83257-019-32) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET",
"NDC11Code": "83257-0019-32",
"ProductNDC": "83257-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hulio",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20231230",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Biocon Biologics Inc",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20231230",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "83257-008-32",
"PackageDescription": "5 SYRINGE in 1 CARTON (83257-008-32) / 3 mL in 1 SYRINGE (83257-008-31) ",
"NDC11Code": "83257-0008-32",
"ProductNDC": "83257-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kirsty",
"NonProprietaryName": "Insulin Aspart-xjhz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761188",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH."
},
{
"NDCCode": "83257-012-32",
"PackageDescription": "3 SYRINGE in 1 CARTON (83257-012-32) / 3 mL in 1 SYRINGE",
"NDC11Code": "83257-0012-32",
"ProductNDC": "83257-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "83257-015-32",
"PackageDescription": "5 SYRINGE in 1 CARTON (83257-015-32) / 3 mL in 1 SYRINGE",
"NDC11Code": "83257-0015-32",
"ProductNDC": "83257-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Glargine",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled Pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine - yfgn has a pH of approximately 4."
},
{
"NDCCode": "83257-022-32",
"PackageDescription": "2 TRAY in 1 KIT (83257-022-32) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET",
"NDC11Code": "83257-0022-32",
"ProductNDC": "83257-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Biocon Biologics Inc",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "31722-019-32",
"PackageDescription": "12 BOTTLE in 1 BOX (31722-019-32) / 120 mL in 1 BOTTLE (31722-019-12) ",
"NDC11Code": "31722-0019-32",
"ProductNDC": "31722-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"NonProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215049",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM",
"StrengthNumber": "660; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Diatrizoate meglumine and diatrizoate sodium solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. Diatrizoate meglumine and diatrizoate sodium solution may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.",
"Description": "Diatrizoate Meglumine and Diatrizoate Sodium Solution, USP is a palatable strawberry-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine USP and 100 mg diatrizoate sodium USP; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodiumand 367 mg organically bound iodine. Inactive ingredients: edetate disodium dihydrate, polysorbate 80, saccharin sodium, simethicone, sodium hydroxide, strawberry flavor and tri-sodium citrate dihydrate. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5- diacetamido-2,4,6-triiodobenzoate (salt); diatrizoate sodium is monosodium 3,5-diacetamido-2,4,6-triiodobenzoate. Structural formulas:. Diatrizoate meglumine C 11H 9I 3N 2O 4.C 7H 17NO 5 Molecular Weight: 809.13 Organically bound Iodine: 47.1%. Diatrizoate sodium C 11H 8I 3N 2NaO 4 Molecular Weight: 635.90 Organically bound Iodine: 59.9%."
},
{
"NDCCode": "52642-019-32",
"PackageDescription": "32 TABLET, CHEWABLE in 1 BAG (52642-019-32) ",
"NDC11Code": "52642-0019-32",
"ProductNDC": "52642-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cherry Antacid Softchew",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140314",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "BestCo Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1177",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140314",
"SamplePackage": "N"
},
{
"NDCCode": "64330-019-32",
"PackageDescription": "27 kg in 1 DRUM (64330-019-32) ",
"NDC11Code": "64330-0019-32",
"ProductNDC": "64330-019",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090217",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2025-07-03",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "27-MAR-17"
},
{
"NDCCode": "69772-019-32",
"PackageDescription": "1 TUBE in 1 CARTON (69772-019-32) > 32 g in 1 TUBE",
"NDC11Code": "69772-0019-32",
"ProductNDC": "69772-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitacilina",
"NonProprietaryName": "Neomycin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150515",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Teresa Cecena DBA Genesis",
"SubstanceName": "NEOMYCIN SULFATE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Clean the affected area. Aplly a small amount of the product on the area 1 to 3 times daily. May be covered with a sterile bandage."
},
{
"NDCCode": "83629-019-32",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (83629-019-32) ",
"NDC11Code": "83629-0019-32",
"ProductNDC": "83629-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nexxgen 50% Rubbing Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240103",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "A & A Nexxgen LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "50",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240103",
"SamplePackage": "N",
"IndicationAndUsage": " first aid to help prevent the risk of infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "72205-019-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (72205-019-01) > 100 mL in 1 BOTTLE",
"NDC11Code": "72205-0019-01",
"ProductNDC": "72205-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valganciclovir Hydrochloride",
"NonProprietaryName": "Valganciclovir Hydrochloride",
"DosageFormName": "FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210169",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2022-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220914",
"SamplePackage": "N",
"IndicationAndUsage": "Valganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.",
"Description": "Valganciclovir for oral solution contains valganciclovir hydrochloride, USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir hydrochloride, USP is available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir for oral solution are fumaric acid, mannitol, povidone K-29/32, saccharin sodium, sodium benzoate, and tutti-frutti flavoring. Valganciclovir hydrochloride, USP is a white to off-white powder with a molecular formula of C14H22N6O5·HCl and a molecular weight of 390.8. The chemical name for valganciclovir hydrochloride is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride is a polar hydrophilic compound with a solubility of 100 mg/mL in water at 25°C at a pH 7.0 and an n-octanol/water partition coefficient of -2.37 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.2. The chemical structure of valganciclovir hydrochloride is:. All doses in this insert are specified in terms of valganciclovir."
},
{
"NDCCode": "85398-019-01",
"PackageDescription": "232 g in 1 CARTON (85398-019-01) ",
"NDC11Code": "85398-0019-01",
"ProductNDC": "85398-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hermon Antifungal Soap.",
"NonProprietaryName": "Tolnaftate 1%",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Beautivity LLC",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "2.32",
"StrengthUnit": "g/232g",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251107",
"SamplePackage": "N"
},
{
"NDCCode": "83257-001-11",
"PackageDescription": "1 VIAL in 1 CARTON (83257-001-11) / 15 mL in 1 VIAL",
"NDC11Code": "83257-0001-11",
"ProductNDC": "83257-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ogivri",
"NonProprietaryName": "Trastuzumab-dkst",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761074",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "TRASTUZUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/7.4mL",
"Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6."
},
{
"NDCCode": "83257-003-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-003-01) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0003-01",
"ProductNDC": "83257-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ogivri",
"NonProprietaryName": "Trastuzumab-dkst",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761074",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "TRASTUZUMAB",
"StrengthNumber": "420",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6."
},
{
"NDCCode": "83257-004-12",
"PackageDescription": "1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11) ",
"NDC11Code": "83257-0004-12",
"ProductNDC": "83257-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ogivri",
"NonProprietaryName": "Trastuzumab-dkst",
"DosageFormName": "KIT",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761074",
"LabelerName": "Biocon Biologics Inc.",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6."
},
{
"NDCCode": "83257-005-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE",
"NDC11Code": "83257-0005-41",
"ProductNDC": "83257-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fulphila",
"NonProprietaryName": "Pegfilgrastim-jmdb",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761075",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "PEGFILGRASTIM",
"StrengthNumber": "6",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Fulphila is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) .",
"Description": "Pegfilgrastim-jmdb is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-jmdb a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-jmdb is approximately 39 kD. Fulphila (pegfilgrastim-jmdb) injection is intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 29 gauge needle, with UltraSafe Passive Plus Needle Guard. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-jmdb (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg) and sodium (0.01 mg) in Water for Injection, USP."
},
{
"NDCCode": "83257-006-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-006-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0006-11",
"ProductNDC": "83257-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Diluting Medium For Kirsty",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761188",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH."
},
{
"NDCCode": "83257-007-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-007-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0007-11",
"ProductNDC": "83257-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kirsty",
"NonProprietaryName": "Insulin Aspart-xjhz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761188",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH."
},
{
"NDCCode": "83257-009-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83257-009-11) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "83257-0009-11",
"ProductNDC": "83257-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jobevne",
"NonProprietaryName": "Bevacizumab-nwgd",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20250410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761175",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250410",
"SamplePackage": "N",
"IndicationAndUsage": "Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .",
"Description": "Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing."
},
{
"NDCCode": "83257-010-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83257-010-11) / 16 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "83257-0010-11",
"ProductNDC": "83257-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jobevne",
"NonProprietaryName": "Bevacizumab-nwgd",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20250410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761175",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250410",
"SamplePackage": "N",
"IndicationAndUsage": "Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .",
"Description": "Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing."
},
{
"NDCCode": "83257-011-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-011-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0011-11",
"ProductNDC": "83257-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230728",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "83257-012-31",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGE",
"NDC11Code": "83257-0012-31",
"ProductNDC": "83257-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"EndMarketingDate": "20270531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230728",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "83257-012-33",
"PackageDescription": "5 SYRINGE in 1 CARTON (83257-012-33) / 3 mL in 1 SYRINGE",
"NDC11Code": "83257-0012-33",
"ProductNDC": "83257-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"EndMarketingDate": "20270531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230728",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
},
{
"NDCCode": "83257-014-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-014-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0014-11",
"ProductNDC": "83257-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Glargine",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled Pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine - yfgn has a pH of approximately 4."
},
{
"NDCCode": "83257-015-31",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-015-31) / 3 mL in 1 SYRINGE",
"NDC11Code": "83257-0015-31",
"ProductNDC": "83257-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Glargine",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled Pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine - yfgn has a pH of approximately 4."
},
{
"NDCCode": "83257-016-42",
"PackageDescription": "2 TRAY in 1 KIT (83257-016-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET",
"NDC11Code": "83257-0016-42",
"ProductNDC": "83257-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hulio",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20231230",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Biocon Biologics Inc",
"Status": "Active",
"LastUpdate": "2026-04-16",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "83257-017-42",
"PackageDescription": "2 TRAY in 1 KIT (83257-017-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET",
"NDC11Code": "83257-0017-42",
"ProductNDC": "83257-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hulio",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20231230",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Biocon Biologics Inc",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "83257-020-42",
"PackageDescription": "2 TRAY in 1 KIT (83257-020-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET",
"NDC11Code": "83257-0020-42",
"ProductNDC": "83257-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Biocon Biologics Inc",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "83257-021-42",
"PackageDescription": "2 TRAY in 1 KIT (83257-021-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET",
"NDC11Code": "83257-0021-42",
"ProductNDC": "83257-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Biocon Biologics Inc",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "83257-023-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE",
"NDC11Code": "83257-0023-41",
"ProductNDC": "83257-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yesintek",
"NonProprietaryName": "Ustekinumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761406",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250222",
"SamplePackage": "Y"
}
]
}
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<NDCList>
<NDC>
<NDCCode>83257-019-32</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (83257-019-32) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>83257-0019-32</NDC11Code>
<ProductNDC>83257-019</ProductNDC>
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<EndMarketingDate>20261031</EndMarketingDate>
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<LabelerName>Biocon Biologics Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20231230</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-008-32</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (83257-008-32) / 3 mL in 1 SYRINGE (83257-008-31) </PackageDescription>
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<ProductNDC>83257-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Insulin Aspart-xjhz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761188</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-012-32</NDCCode>
<PackageDescription>3 SYRINGE in 1 CARTON (83257-012-32) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0012-32</NDC11Code>
<ProductNDC>83257-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>83257-015-32</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (83257-015-32) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0015-32</NDC11Code>
<ProductNDC>83257-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Glargine</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled Pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine - yfgn has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>83257-022-32</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (83257-022-32) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>83257-0022-32</NDC11Code>
<ProductNDC>83257-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Biocon Biologics Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>31722-019-32</NDCCode>
<PackageDescription>12 BOTTLE in 1 BOX (31722-019-32) / 120 mL in 1 BOTTLE (31722-019-12) </PackageDescription>
<NDC11Code>31722-0019-32</NDC11Code>
<ProductNDC>31722-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</ProprietaryName>
<NonProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215049</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM</SubstanceName>
<StrengthNumber>660; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diatrizoate meglumine and diatrizoate sodium solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. Diatrizoate meglumine and diatrizoate sodium solution may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.</IndicationAndUsage>
<Description>Diatrizoate Meglumine and Diatrizoate Sodium Solution, USP is a palatable strawberry-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine USP and 100 mg diatrizoate sodium USP; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodiumand 367 mg organically bound iodine. Inactive ingredients: edetate disodium dihydrate, polysorbate 80, saccharin sodium, simethicone, sodium hydroxide, strawberry flavor and tri-sodium citrate dihydrate. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5- diacetamido-2,4,6-triiodobenzoate (salt); diatrizoate sodium is monosodium 3,5-diacetamido-2,4,6-triiodobenzoate. Structural formulas:. Diatrizoate meglumine C 11H 9I 3N 2O 4.C 7H 17NO 5 Molecular Weight: 809.13 Organically bound Iodine: 47.1%. Diatrizoate sodium C 11H 8I 3N 2NaO 4 Molecular Weight: 635.90 Organically bound Iodine: 59.9%.</Description>
</NDC>
<NDC>
<NDCCode>52642-019-32</NDCCode>
<PackageDescription>32 TABLET, CHEWABLE in 1 BAG (52642-019-32) </PackageDescription>
<NDC11Code>52642-0019-32</NDC11Code>
<ProductNDC>52642-019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cherry Antacid Softchew</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140314</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>BestCo Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1177</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64330-019-32</NDCCode>
<PackageDescription>27 kg in 1 DRUM (64330-019-32) </PackageDescription>
<NDC11Code>64330-0019-32</NDC11Code>
<ProductNDC>64330-019</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20090217</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2025-07-03</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-MAR-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69772-019-32</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69772-019-32) > 32 g in 1 TUBE</PackageDescription>
<NDC11Code>69772-0019-32</NDC11Code>
<ProductNDC>69772-019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitacilina</ProprietaryName>
<NonProprietaryName>Neomycin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Teresa Cecena DBA Genesis</LabelerName>
<SubstanceName>NEOMYCIN SULFATE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clean the affected area. Aplly a small amount of the product on the area 1 to 3 times daily. May be covered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83629-019-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (83629-019-32) </PackageDescription>
<NDC11Code>83629-0019-32</NDC11Code>
<ProductNDC>83629-019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nexxgen 50% Rubbing Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>A & A Nexxgen LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> first aid to help prevent the risk of infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72205-019-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72205-019-01) > 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72205-0019-01</NDC11Code>
<ProductNDC>72205-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valganciclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
<DosageFormName>FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210169</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
<Description>Valganciclovir for oral solution contains valganciclovir hydrochloride, USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir hydrochloride, USP is available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir for oral solution are fumaric acid, mannitol, povidone K-29/32, saccharin sodium, sodium benzoate, and tutti-frutti flavoring. Valganciclovir hydrochloride, USP is a white to off-white powder with a molecular formula of C14H22N6O5·HCl and a molecular weight of 390.8. The chemical name for valganciclovir hydrochloride is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride is a polar hydrophilic compound with a solubility of 100 mg/mL in water at 25°C at a pH 7.0 and an n-octanol/water partition coefficient of -2.37 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.2. The chemical structure of valganciclovir hydrochloride is:. All doses in this insert are specified in terms of valganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>85398-019-01</NDCCode>
<PackageDescription>232 g in 1 CARTON (85398-019-01) </PackageDescription>
<NDC11Code>85398-0019-01</NDC11Code>
<ProductNDC>85398-019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hermon Antifungal Soap.</ProprietaryName>
<NonProprietaryName>Tolnaftate 1%</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Beautivity LLC</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>2.32</StrengthNumber>
<StrengthUnit>g/232g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83257-001-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83257-001-11) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>83257-0001-11</NDC11Code>
<ProductNDC>83257-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ogivri</ProprietaryName>
<NonProprietaryName>Trastuzumab-dkst</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761074</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>TRASTUZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/7.4mL</StrengthUnit>
<Pharm_Classes>HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>83257-003-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-003-01) / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0003-01</NDC11Code>
<ProductNDC>83257-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ogivri</ProprietaryName>
<NonProprietaryName>Trastuzumab-dkst</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761074</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>TRASTUZUMAB</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>83257-004-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11) </PackageDescription>
<NDC11Code>83257-0004-12</NDC11Code>
<ProductNDC>83257-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ogivri</ProprietaryName>
<NonProprietaryName>Trastuzumab-dkst</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761074</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>83257-005-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0005-41</NDC11Code>
<ProductNDC>83257-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fulphila</ProprietaryName>
<NonProprietaryName>Pegfilgrastim-jmdb</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761075</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>PEGFILGRASTIM</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fulphila is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) .</IndicationAndUsage>
<Description>Pegfilgrastim-jmdb is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-jmdb a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-jmdb is approximately 39 kD. Fulphila (pegfilgrastim-jmdb) injection is intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 29 gauge needle, with UltraSafe Passive Plus Needle Guard. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-jmdb (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg) and sodium (0.01 mg) in Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>83257-006-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-006-11) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0006-11</NDC11Code>
<ProductNDC>83257-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Diluting Medium For Kirsty</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761188</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-007-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-007-11) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0007-11</NDC11Code>
<ProductNDC>83257-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kirsty</ProprietaryName>
<NonProprietaryName>Insulin Aspart-xjhz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761188</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-009-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (83257-009-11) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>83257-0009-11</NDC11Code>
<ProductNDC>83257-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jobevne</ProprietaryName>
<NonProprietaryName>Bevacizumab-nwgd</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20250410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761175</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .</IndicationAndUsage>
<Description>Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing.</Description>
</NDC>
<NDC>
<NDCCode>83257-010-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (83257-010-11) / 16 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>83257-0010-11</NDC11Code>
<ProductNDC>83257-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jobevne</ProprietaryName>
<NonProprietaryName>Bevacizumab-nwgd</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20250410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761175</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .</IndicationAndUsage>
<Description>Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing.</Description>
</NDC>
<NDC>
<NDCCode>83257-011-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-011-11) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0011-11</NDC11Code>
<ProductNDC>83257-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>83257-012-31</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0012-31</NDC11Code>
<ProductNDC>83257-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<EndMarketingDate>20270531</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>83257-012-33</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (83257-012-33) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0012-33</NDC11Code>
<ProductNDC>83257-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<EndMarketingDate>20270531</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>83257-014-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-014-11) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0014-11</NDC11Code>
<ProductNDC>83257-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Glargine</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled Pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine - yfgn has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>83257-015-31</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-015-31) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0015-31</NDC11Code>
<ProductNDC>83257-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Glargine</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled Pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine - yfgn has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>83257-016-42</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (83257-016-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>83257-0016-42</NDC11Code>
<ProductNDC>83257-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hulio</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231230</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Biocon Biologics Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20231230</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-017-42</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (83257-017-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>83257-0017-42</NDC11Code>
<ProductNDC>83257-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hulio</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231230</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Biocon Biologics Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20231230</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HULIO is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HULIO (adalimumab-fkjp) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HULIO Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of HULIO is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HULIO contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HULIO contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-020-42</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (83257-020-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>83257-0020-42</NDC11Code>
<ProductNDC>83257-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Biocon Biologics Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-021-42</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (83257-021-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>83257-0021-42</NDC11Code>
<ProductNDC>83257-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Biocon Biologics Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-023-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0023-41</NDC11Code>
<ProductNDC>83257-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yesintek</ProprietaryName>
<NonProprietaryName>Ustekinumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761406</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250222</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
</NDCList>