{
"NDC": [
{
"NDCCode": "0074-3799-06",
"PackageDescription": "6 KIT in 1 CARTON (0074-3799-06) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .8 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-3799-06",
"ProductNDC": "0074-3799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20021231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20021231",
"SamplePackage": "N"
},
{
"NDCCode": "0074-3799-02",
"PackageDescription": "2 KIT in 1 CARTON (0074-3799-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-3799-02",
"ProductNDC": "0074-3799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20021231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20021231",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: : 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 rheumatoid arthritis. (1.1) , 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 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. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. 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 HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "0074-3799-03",
"PackageDescription": "3 KIT in 1 CARTON (0074-3799-03) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .8 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-3799-03",
"ProductNDC": "0074-3799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20021231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20021231",
"SamplePackage": "N"
},
{
"NDCCode": "0074-3799-71",
"PackageDescription": "2 KIT in 1 CARTON (0074-3799-71) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .8 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-3799-71",
"ProductNDC": "0074-3799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20021231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2020-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20021231",
"SamplePackage": "Y"
},
{
"NDCCode": "0074-0554-06",
"PackageDescription": "6 KIT in 1 CARTON (0074-0554-06) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .4 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-0554-06",
"ProductNDC": "0074-0554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20160309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2021-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160309",
"SamplePackage": "N"
},
{
"NDCCode": "0074-4339-06",
"PackageDescription": "6 KIT in 1 CARTON (0074-4339-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-4339-06",
"ProductNDC": "0074-4339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20060623",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20060623",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 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. , 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. , 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen), as a single-dose, 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH."
},
{
"NDCCode": "0074-7098-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (0074-7098-06) / 5 mL in 1 BOTTLE",
"NDC11Code": "00074-7098-06",
"ProductNDC": "0074-7098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vuity",
"NonProprietaryName": "Pilocarpine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20211028",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214028",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PILOCARPINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230308",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "VUITY® is indicated for the treatment of presbyopia in adults.",
"Description": "VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, clear, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride. The chemical name for pilocarpine hydrochloride is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]oxolan-2-one hydrochloride. Its molecular weight is 244.72 and its molecular formula is C11H16N2O2 · HCl. Its structural formula is. Each mL of VUITY contains pilocarpine hydrochloride 1.25% (12.5 mg) as the active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative is: benzalkonium chloride 0.0075%. Inactive ingredients in the ophthalmic solution are: boric acid, sodium citrate dihydrate, sodium chloride, purified water, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary."
},
{
"NDCCode": "0135-0074-06",
"PackageDescription": "70 TABLET in 1 BOTTLE (0135-0074-06) ",
"NDC11Code": "00135-0074-06",
"ProductNDC": "0135-0074",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums",
"ProprietaryNameSuffix": "Ex",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100118",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "49348-074-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (49348-074-06) > 32 CAPSULE in 1 BOTTLE",
"NDC11Code": "49348-0074-06",
"ProductNDC": "49348-074",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100709",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "McKesson (Sunmark)",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100709",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "68382-074-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-074-06) ",
"NDC11Code": "68382-0074-06",
"ProductNDC": "68382-074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078900",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171205",
"SamplePackage": "N",
"IndicationAndUsage": "Finasteride tablets, are 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): 1 Improve symptoms , 2 Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. .",
"Description": "Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The molecular formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:. Finasteride, USP is a white to off-white, crystalline solid which melts between 251(C and 258(C. It is freely soluble in chloroform and in alcohol. Each finasteride tablet intended for oral administration contains 5 mg of finasteride. In addition, each tablet contains the following inactive ingredients: docusate sodium, FD&C blue # 2, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. The tablet is printed with black pharmaceutical ink which contains following major ingredients: Shellac Glaze and black iron oxide. The starch source for sodium starch glycolate is potato starch and for Pregelatinized starch is corn starch."
},
{
"NDCCode": "68788-0074-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68788-0074-6) ",
"NDC11Code": "68788-0074-06",
"ProductNDC": "68788-0074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075828",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130318",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0074-6",
"PackageDescription": "7 TABLET in 1 BOTTLE (71335-0074-6) ",
"NDC11Code": "71335-0074-06",
"ProductNDC": "71335-0074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phendimetrazine Tartrate",
"NonProprietaryName": "Phendimetrazine Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091042",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PHENDIMETRAZINE TARTRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170918",
"SamplePackage": "N",
"IndicationAndUsage": "Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.",
"Description": "Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)- tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each white tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, the following inactive ingredients are present: Colloidal Silicon Dioxide, Lactose Monohydrate, Microcrystalline Cellulose 102, Sodium Starch Glycolate and Stearic Acid. The yellow tablet also contains FD&C Yellow # 5 Aluminum Lake (15-17%). The blue tablet also contains FD&C Blue # 1 Aluminum Lake (11-13%)."
},
{
"NDCCode": "72789-074-06",
"PackageDescription": "6 CAPSULE in 1 BOTTLE, PLASTIC (72789-074-06) ",
"NDC11Code": "72789-0074-06",
"ProductNDC": "72789-074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190403",
"EndMarketingDate": "20221101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201105",
"EndMarketingDatePackage": "20221101",
"SamplePackage": "N"
},
{
"NDCCode": "80425-0074-6",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE (80425-0074-6) ",
"NDC11Code": "80425-0074-06",
"ProductNDC": "80425-0074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hcl",
"NonProprietaryName": "Ondansetron Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Advanced Rx of Tennessee, LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200916",
"SamplePackage": "N",
"IndicationAndUsage": "1 INDICATIONS AND USAGE. Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow. Meets USP dissolution test 6."
},
{
"NDCCode": "70518-3799-0",
"PackageDescription": "100 POUCH in 1 BOX (70518-3799-0) / 1 CAPSULE in 1 POUCH (70518-3799-1) ",
"NDC11Code": "70518-3799-00",
"ProductNDC": "70518-3799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230718",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090055",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230718",
"EndMarketingDatePackage": "20271231",
"SamplePackage": "N",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "0074-0067-02",
"PackageDescription": "2 KIT in 1 CARTON (0074-0067-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKAGE * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE",
"NDC11Code": "00074-0067-02",
"ProductNDC": "0074-0067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20161017",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161017",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 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. , 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. , 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen), as a single-dose, 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH."
},
{
"NDCCode": "0074-0243-71",
"PackageDescription": "2 KIT in 1 CARTON (0074-0243-71) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-0243-71",
"ProductNDC": "0074-0243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20151123",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151123",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "Y",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 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. , 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. , 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen), as a single-dose, 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH."
},
{
"NDCCode": "0074-0282-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0074-0282-02) / 1.15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00074-0282-02",
"ProductNDC": "0074-0282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Decnupaz",
"NonProprietaryName": "Pivekimab Sunirine-pvzy",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260527",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761460",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PIVEKIMAB SUNIRINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260527",
"SamplePackage": "N",
"IndicationAndUsage": "DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).",
"Description": "Pivekimab sunirine-pvzy is a CD123-directed antibody and alkylating agent conjugate created by conjugating the IgG1 monoclonal antibody G4723A to the DGN549C linker-payload. The antibody-drug conjugate (ADC) contains approximately two DGN549C molecules sulfonated prior to conjugation and bound to the heavy chains (HC) of the G4723A antibody. Pivekimab sunirine-pvzy has an approximate molecular weight of 148 kDa. Pivekimab sunirine-pvzy is produced by site directed chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis. Pivekimab sunirine-pvzy has the following structure:. DECNUPAZ (pivekimab sunirine-pvzy) for injection is a sterile, lyophilized cake in a single-dose vial for reconstitution and dilution. DECNUPAZ is supplied as 2 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL) to obtain a concentration of 2 mg/mL. Following reconstitution, each mL delivers 2 mg of pivekimab sunirine-pvzy, methionine (0.45 mg), polysorbate 20 (0.1 mg), sodium hydroxide (0.2 mg), sodium metabisulfite (0.0048 mg), succinic acid (1.2 mg), trehalose (71.7 mg), and Sterile Water for Injection. The pH is 4.2."
},
{
"NDCCode": "0074-0554-04",
"PackageDescription": "4 KIT in 1 CARTON (0074-0554-04) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .4 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-0554-04",
"ProductNDC": "0074-0554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20160309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2021-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160309",
"SamplePackage": "N"
},
{
"NDCCode": "0074-0554-73",
"PackageDescription": "6 KIT in 1 CARTON (0074-0554-73) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .4 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "00074-0554-73",
"ProductNDC": "0074-0554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20160309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2021-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160309",
"SamplePackage": "Y"
},
{
"NDCCode": "0074-0561-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0561-11",
"ProductNDC": "0074-0561",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160411",
"SamplePackage": "N",
"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-0561-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0561-14",
"ProductNDC": "0074-0561",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160411",
"SamplePackage": "N",
"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-0566-07",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-0566-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0566-07",
"ProductNDC": "0074-0566",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
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"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-0566-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-0566-11) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
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"ProductNDC": "0074-0566",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
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"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-0576-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-0576-11) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0576-11",
"ProductNDC": "0074-0576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-0576-22",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0074-0576-22) ",
"NDC11Code": "00074-0576-22",
"ProductNDC": "0074-0576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-0576-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0074-0576-30) / 28 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00074-0576-30",
"ProductNDC": "0074-0576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-0579-28",
"PackageDescription": "1 KIT in 1 CARTON (0074-0579-28) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-0579-28",
"ProductNDC": "0074-0579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "KIT",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-1044-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0074-1044-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00074-1044-01",
"ProductNDC": "0074-1044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emrelis",
"NonProprietaryName": "Telisotuzumab Vedotin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761384",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "TELISOTUZUMAB VEDOTIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received a prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration (2.4)]. Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0."
},
{
"NDCCode": "0074-1055-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0074-1055-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00074-1055-01",
"ProductNDC": "0074-1055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emrelis",
"NonProprietaryName": "Telisotuzumab Vedotin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761384",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "TELISOTUZUMAB VEDOTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received a prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration (2.4)]. Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0."
}
]
}
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<NDC>
<NDCCode>0074-3799-06</NDCCode>
<PackageDescription>6 KIT in 1 CARTON (0074-3799-06) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .8 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-3799-06</NDC11Code>
<ProductNDC>0074-3799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20021231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-3799-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0074-3799-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-3799-02</NDC11Code>
<ProductNDC>0074-3799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20021231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: : 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 rheumatoid arthritis. (1.1) , 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 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. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. 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 HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
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<NDCCode>0074-3799-03</NDCCode>
<PackageDescription>3 KIT in 1 CARTON (0074-3799-03) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .8 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
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<StartMarketingDate>20021231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0074-3799-71</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0074-3799-71) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .8 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-3799-71</NDC11Code>
<ProductNDC>0074-3799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021231</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
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<NDC>
<NDCCode>0074-0554-06</NDCCode>
<PackageDescription>6 KIT in 1 CARTON (0074-0554-06) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .4 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-0554-06</NDC11Code>
<ProductNDC>0074-0554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0074-4339-06</NDCCode>
<PackageDescription>6 KIT in 1 CARTON (0074-4339-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-4339-06</NDC11Code>
<ProductNDC>0074-4339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060623</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
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<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 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. , 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. , 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. .</IndicationAndUsage>
<Description>Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen), as a single-dose, 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-7098-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0074-7098-06) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-7098-06</NDC11Code>
<ProductNDC>0074-7098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vuity</ProprietaryName>
<NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20211028</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214028</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230308</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VUITY® is indicated for the treatment of presbyopia in adults.</IndicationAndUsage>
<Description>VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, clear, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride. The chemical name for pilocarpine hydrochloride is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]oxolan-2-one hydrochloride. Its molecular weight is 244.72 and its molecular formula is C11H16N2O2 · HCl. Its structural formula is. Each mL of VUITY contains pilocarpine hydrochloride 1.25% (12.5 mg) as the active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative is: benzalkonium chloride 0.0075%. Inactive ingredients in the ophthalmic solution are: boric acid, sodium citrate dihydrate, sodium chloride, purified water, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary.</Description>
</NDC>
<NDC>
<NDCCode>0135-0074-06</NDCCode>
<PackageDescription>70 TABLET in 1 BOTTLE (0135-0074-06) </PackageDescription>
<NDC11Code>00135-0074-06</NDC11Code>
<ProductNDC>0135-0074</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums</ProprietaryName>
<ProprietaryNameSuffix>Ex</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49348-074-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49348-074-06) > 32 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>49348-0074-06</NDC11Code>
<ProductNDC>49348-074</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100709</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>McKesson (Sunmark)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100709</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-074-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-074-06) </PackageDescription>
<NDC11Code>68382-0074-06</NDC11Code>
<ProductNDC>68382-074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078900</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finasteride tablets, are 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): 1 Improve symptoms , 2 Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. .</IndicationAndUsage>
<Description>Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The molecular formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:. Finasteride, USP is a white to off-white, crystalline solid which melts between 251(C and 258(C. It is freely soluble in chloroform and in alcohol. Each finasteride tablet intended for oral administration contains 5 mg of finasteride. In addition, each tablet contains the following inactive ingredients: docusate sodium, FD&C blue # 2, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. The tablet is printed with black pharmaceutical ink which contains following major ingredients: Shellac Glaze and black iron oxide. The starch source for sodium starch glycolate is potato starch and for Pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68788-0074-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-0074-6) </PackageDescription>
<NDC11Code>68788-0074-06</NDC11Code>
<ProductNDC>68788-0074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075828</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0074-6</NDCCode>
<PackageDescription>7 TABLET in 1 BOTTLE (71335-0074-6) </PackageDescription>
<NDC11Code>71335-0074-06</NDC11Code>
<ProductNDC>71335-0074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
<NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091042</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PHENDIMETRAZINE TARTRATE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)- tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each white tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, the following inactive ingredients are present: Colloidal Silicon Dioxide, Lactose Monohydrate, Microcrystalline Cellulose 102, Sodium Starch Glycolate and Stearic Acid. The yellow tablet also contains FD&C Yellow # 5 Aluminum Lake (15-17%). The blue tablet also contains FD&C Blue # 1 Aluminum Lake (11-13%).</Description>
</NDC>
<NDC>
<NDCCode>72789-074-06</NDCCode>
<PackageDescription>6 CAPSULE in 1 BOTTLE, PLASTIC (72789-074-06) </PackageDescription>
<NDC11Code>72789-0074-06</NDC11Code>
<ProductNDC>72789-074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190403</StartMarketingDate>
<EndMarketingDate>20221101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201105</StartMarketingDatePackage>
<EndMarketingDatePackage>20221101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80425-0074-6</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BOTTLE (80425-0074-6) </PackageDescription>
<NDC11Code>80425-0074-06</NDC11Code>
<ProductNDC>80425-0074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hcl</ProprietaryName>
<NonProprietaryName>Ondansetron Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1 INDICATIONS AND USAGE. Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>70518-3799-0</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (70518-3799-0) / 1 CAPSULE in 1 POUCH (70518-3799-1) </PackageDescription>
<NDC11Code>70518-3799-00</NDC11Code>
<ProductNDC>70518-3799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230718</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090055</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230718</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0074-0067-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0074-0067-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKAGE * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00074-0067-02</NDC11Code>
<ProductNDC>0074-0067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161017</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161017</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 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. , 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. , 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. .</IndicationAndUsage>
<Description>Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen), as a single-dose, 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-0243-71</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0074-0243-71) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-0243-71</NDC11Code>
<ProductNDC>0074-0243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151123</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151123</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 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. , 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. , 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. .</IndicationAndUsage>
<Description>Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen), as a single-dose, 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-0282-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0074-0282-02) / 1.15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00074-0282-02</NDC11Code>
<ProductNDC>0074-0282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Decnupaz</ProprietaryName>
<NonProprietaryName>Pivekimab Sunirine-pvzy</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260527</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761460</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PIVEKIMAB SUNIRINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).</IndicationAndUsage>
<Description>Pivekimab sunirine-pvzy is a CD123-directed antibody and alkylating agent conjugate created by conjugating the IgG1 monoclonal antibody G4723A to the DGN549C linker-payload. The antibody-drug conjugate (ADC) contains approximately two DGN549C molecules sulfonated prior to conjugation and bound to the heavy chains (HC) of the G4723A antibody. Pivekimab sunirine-pvzy has an approximate molecular weight of 148 kDa. Pivekimab sunirine-pvzy is produced by site directed chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis. Pivekimab sunirine-pvzy has the following structure:. DECNUPAZ (pivekimab sunirine-pvzy) for injection is a sterile, lyophilized cake in a single-dose vial for reconstitution and dilution. DECNUPAZ is supplied as 2 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL) to obtain a concentration of 2 mg/mL. Following reconstitution, each mL delivers 2 mg of pivekimab sunirine-pvzy, methionine (0.45 mg), polysorbate 20 (0.1 mg), sodium hydroxide (0.2 mg), sodium metabisulfite (0.0048 mg), succinic acid (1.2 mg), trehalose (71.7 mg), and Sterile Water for Injection. The pH is 4.2.</Description>
</NDC>
<NDC>
<NDCCode>0074-0554-04</NDCCode>
<PackageDescription>4 KIT in 1 CARTON (0074-0554-04) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .4 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-0554-04</NDC11Code>
<ProductNDC>0074-0554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-0554-73</NDCCode>
<PackageDescription>6 KIT in 1 CARTON (0074-0554-73) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .4 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00074-0554-73</NDC11Code>
<ProductNDC>0074-0554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160309</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-0561-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-0561-11</NDC11Code>
<ProductNDC>0074-0561</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venclexta</ProprietaryName>
<NonProprietaryName>Venetoclax</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208573</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>VENETOCLAX</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
</NDC>
<NDC>
<NDCCode>0074-0561-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-0561-14</NDC11Code>
<ProductNDC>0074-0561</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venclexta</ProprietaryName>
<NonProprietaryName>Venetoclax</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208573</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>VENETOCLAX</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
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<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
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<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
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<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
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<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
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<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
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<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
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<IndicationAndUsage>EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received a prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration (2.4)]. Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0.</Description>
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<IndicationAndUsage>EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received a prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration (2.4)]. Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0.</Description>
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