{
"NDC": [
{
"NDCCode": "0025-1520-51",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0025-1520-51) ",
"NDC11Code": "00025-1520-51",
"ProductNDC": "0025-1520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "PFIZER LABORATORIES DIV PFIZER INC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19981002",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "CELEBREX is indicated.",
"Description": "CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "0025-1520-31",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0025-1520-31) ",
"NDC11Code": "00025-1520-31",
"ProductNDC": "0025-1520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "PFIZER LABORATORIES DIV PFIZER INC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19981002",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "CELEBREX is indicated.",
"Description": "CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "0025-1520-34",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0025-1520-34) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00025-1520-34",
"ProductNDC": "0025-1520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "PFIZER LABORATORIES DIV PFIZER INC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19981002",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "CELEBREX is indicated.",
"Description": "CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "0025-0061-51",
"PackageDescription": "500 TABLET in 1 BOTTLE (0025-0061-51)",
"NDC11Code": "00025-0061-51",
"ProductNDC": "0025-0061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lomotil",
"NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19600915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012462",
"LabelerName": "G.D. Searle LLC Division of Pfizer Inc",
"SubstanceName": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
"StrengthNumber": ".025; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2014-10-10"
},
{
"NDCCode": "0025-1381-51",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0025-1381-51) ",
"NDC11Code": "00025-1381-51",
"ProductNDC": "0025-1381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daypro",
"NonProprietaryName": "Oxaprozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19921029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018841",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "OXAPROZIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19921029",
"SamplePackage": "N"
},
{
"NDCCode": "0025-1525-51",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0025-1525-51) ",
"NDC11Code": "00025-1525-51",
"ProductNDC": "0025-1525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "PFIZER LABORATORIES DIV PFIZER INC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19981002",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "CELEBREX is indicated.",
"Description": "CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "0025-1891-51",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0025-1891-51) ",
"NDC11Code": "00025-1891-51",
"ProductNDC": "0025-1891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calan Sr",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19861216",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019152",
"LabelerName": "G.D. Searle LLC Division of Pfizer Inc",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19861216",
"EndMarketingDatePackage": "20190131",
"SamplePackage": "N"
},
{
"NDCCode": "0025-2732-51",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-51)",
"NDC11Code": "00025-2732-51",
"ProductNDC": "0025-2732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpace Cr",
"NonProprietaryName": "Disopyramide Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19820720",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018655",
"LabelerName": "G.D. Searle LLC Division of Pfizer Inc",
"SubstanceName": "DISOPYRAMIDE PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-09-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0025-2742-51",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2742-51)",
"NDC11Code": "00025-2742-51",
"ProductNDC": "0025-2742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpace Cr",
"NonProprietaryName": "Disopyramide Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19820720",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018655",
"LabelerName": "G.D. Searle LLC Division of Pfizer Inc",
"SubstanceName": "DISOPYRAMIDE PHOSPHATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-09-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "81033-025-51",
"PackageDescription": "5 TUBE in 1 CARTON (81033-025-51) / 5 g in 1 TUBE (81033-025-05) ",
"NDC11Code": "81033-0025-51",
"ProductNDC": "81033-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Prilocaine",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212482",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. normal intact skinfor local analgesia. genital mucous membranesfor superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and Prilocaine Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).",
"Description": "DESCRIPTION. Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 1 and 5 gram Unit Dose tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. C 14H 22N 2O M.W. 234.3. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. C 13H 20N 2O M.W. 220.3. Each gram of Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, PEG-60 hydrogenated castor oil (as emulsifier), carbomer homopolymer Type B (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of Lidocaine and Prilocaine Cream is 1.00."
},
{
"NDCCode": "82442-025-51",
"PackageDescription": "1 TUBE in 1 CARTON (82442-025-51) / 51 g in 1 TUBE",
"NDC11Code": "82442-0025-51",
"ProductNDC": "82442-025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Hemorrhoid Max Strength",
"NonProprietaryName": "14.4% Glycerin, 0.25% Phenylephrine Hcl, 1% Pramoxine Hcl, 15% Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Target Corporation",
"SubstanceName": "GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM",
"StrengthNumber": "144; 2.5; 10; 150",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful."
},
{
"NDCCode": "0025-0325-01",
"PackageDescription": "1 KIT in 1 CARTON (0025-0325-01) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) ",
"NDC11Code": "00025-0325-01",
"ProductNDC": "0025-0325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
"NonProprietaryName": "Adalimumab-afzb",
"DosageFormName": "KIT",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761118",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "0025-0325-02",
"PackageDescription": "2 KIT in 1 CARTON (0025-0325-02) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) ",
"NDC11Code": "00025-0325-02",
"ProductNDC": "0025-0325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
"NonProprietaryName": "Adalimumab-afzb",
"DosageFormName": "KIT",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761118",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "0025-0328-02",
"PackageDescription": "2 KIT in 1 CARTON (0025-0328-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0025-0317-01) * 1 mL in 1 PACKET (0069-1111-01) ",
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"ProductNDC": "0025-0328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
"NonProprietaryName": "Adalimumab-afzb",
"DosageFormName": "KIT",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761118",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"LastUpdate": "2026-05-07",
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"IndicationAndUsage": "ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "0025-0333-02",
"PackageDescription": "2 KIT in 1 CARTON (0025-0333-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (0025-0329-01) * 1 mL in 1 PACKET (0069-1111-01) ",
"NDC11Code": "00025-0333-02",
"ProductNDC": "0025-0333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
"NonProprietaryName": "Adalimumab-afzb",
"DosageFormName": "KIT",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761118",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-05-07",
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"IndicationAndUsage": "ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
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"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 BOX (11673-572-24) > 51 g in 1 TUBE, WITH APPLICATOR",
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"ProductNDC": "11673-572",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glycerin, Phenylephrine Hydrochloride, Pramoxine, White Petrolatum",
"NonProprietaryName": "Glycerin, Phenylephrine Hydrochloride, Pramoxine, White Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "RECTAL; TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Target Corporation",
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"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
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"IndicationAndUsage": "Temporarily relieves pain, soreness and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful."
},
{
"NDCCode": "42388-025-26",
"PackageDescription": "30 TABLET in 1 BOTTLE (42388-025-26) ",
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"ProductNDC": "42388-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"LabelerName": "Exelixis, Inc.",
"SubstanceName": "CABOZANTINIB S-MALATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
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"IndicationAndUsage": "CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).",
"Description": "CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow."
},
{
"NDCCode": "42388-025-37",
"PackageDescription": "15 TABLET in 1 BOTTLE (42388-025-37) ",
"NDC11Code": "42388-0025-37",
"ProductNDC": "42388-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabometyx",
"NonProprietaryName": "Cabozantinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160425",
"MarketingCategoryName": "NDA",
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"LabelerName": "Exelixis, Inc.",
"SubstanceName": "CABOZANTINIB S-MALATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
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"IndicationAndUsage": "CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).",
"Description": "CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow."
},
{
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"ProductNDC": "42388-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabometyx",
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"LabelerName": "Exelixis, Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
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"IndicationAndUsage": "CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).",
"Description": "CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow."
},
{
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"IndicationAndUsage": "CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).",
"Description": "CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
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"DosageFormName": "KIT",
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"MarketingCategoryName": "BLA",
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"LabelerName": "A-S Medication Solutions",
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"SamplePackage": "N",
"IndicationAndUsage": "ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "50090-8032-0",
"PackageDescription": "1 KIT in 1 KIT (50090-8032-0) * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0025-0317-01) * 1 mL in 1 PACKET (0069-1111-01) ",
"NDC11Code": "50090-8032-00",
"ProductNDC": "50090-8032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
"NonProprietaryName": "Adalimumab-afzb",
"DosageFormName": "KIT",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761118",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260805",
"SamplePackage": "N",
"IndicationAndUsage": "ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "55490-025-01",
"PackageDescription": "5 CLOTH in 1 PACKET (55490-025-01) ",
"NDC11Code": "55490-0025-01",
"ProductNDC": "55490-025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Alcohol Wipes",
"NonProprietaryName": "Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200910",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Baijieyuan Biotechnology (Shandong) Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "19",
"StrengthUnit": "mL/51",
"Status": "Deprecated",
"LastUpdate": "2021-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200910",
"SamplePackage": "N"
},
{
"NDCCode": "83860-025-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (83860-025-01) ",
"NDC11Code": "83860-0025-01",
"ProductNDC": "83860-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vykat Xr",
"NonProprietaryName": "Diazoxide Choline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216665",
"LabelerName": "Soleno Therapeutics, Inc.",
"SubstanceName": "DIAZOXIDE CHOLINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).",
"Description": "VYKAT XR contains diazoxide choline. Diazoxide choline is very slightly soluble to soluble in solvents dichloromethane, tetrahydrofuran, acetonitrile, and methanol and practically insoluble in solvents methyl tert-butyl ether. The pKa is 8.44 ± 0.01. Diazoxide choline is 7-Chloro-3-methyl-1λ6, 2,4-benzothiadiazin-2-ide 1,1-dioxide 2- hydroxyethyl(trimethyl)azanium. The empirical formula is C8H6ClN2O2SC5H14NO and the molecular weight is 333.83 g/mole. The structural formula is. VYKAT XR is for oral administration and is available as extended-release tablets in the following strengths: 25 mg tablet contains diazoxide choline 25 mg, equivalent to 17.2 mg diazoxide; 75 mg tablet contains diazoxide choline 75 mg, equivalent to 51.6 mg diazoxide; and 150 mg tablet contains diazoxide choline 150 mg, equivalent to 103.2 mg diazoxide. Each tablet contains the following inactive ingredients: carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene oxide, silicified microcrystalline cellulose, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "0069-1520-68",
"PackageDescription": "90 TABLET in 1 BOTTLE (0069-1520-68) ",
"NDC11Code": "00069-1520-68",
"ProductNDC": "0069-1520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norvasc",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920731",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019787",
"LabelerName": "PFIZER LABORATORIES DIV PFIZER INC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920731",
"EndMarketingDatePackage": "20271031",
"SamplePackage": "N",
"IndicationAndUsage": "NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1)NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. NORVASC (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "0110-1520-01",
"PackageDescription": "69000 CAPSULE in 1 DRUM (0110-1520-01) ",
"NDC11Code": "00110-1520-01",
"ProductNDC": "0110-1520",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20251112",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Lilly del Caribe, Inc.",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": "24",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-19",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "12-NOV-25"
},
{
"NDCCode": "0268-1520-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-1520-10) ",
"NDC11Code": "00268-1520-10",
"ProductNDC": "0268-1520",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Amaranthus Tuberculatus Pollen",
"NonProprietaryName": "Water Hemp",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AMARANTHUS TUBERCULATUS POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N"
},
{
"NDCCode": "0268-1520-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-1520-50) ",
"NDC11Code": "00268-1520-50",
"ProductNDC": "0268-1520",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Amaranthus Tuberculatus Pollen",
"NonProprietaryName": "Water Hemp",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AMARANTHUS TUBERCULATUS POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N"
},
{
"NDCCode": "0280-1520-04",
"PackageDescription": "2 POUCH in 1 CARTON (0280-1520-04) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-1520-04",
"ProductNDC": "0280-1520",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20170703",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "325; 7.8; 2",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. · temporarily relieves these symptoms due to a cold. · minor aches and pains · headache · runny nose. · nasal and sinus congestion · sneezing · sore throat. · temporarily reduces fever."
},
{
"NDCCode": "0280-1520-20",
"PackageDescription": "10 POUCH in 1 CARTON (0280-1520-20) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-1520-20",
"ProductNDC": "0280-1520",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20170703",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "325; 7.8; 2",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170703",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. · temporarily relieves these symptoms due to a cold. · minor aches and pains · headache · runny nose. · nasal and sinus congestion · sneezing · sore throat. · temporarily reduces fever."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0025-1520-51</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0025-1520-51) </PackageDescription>
<NDC11Code>00025-1520-51</NDC11Code>
<ProductNDC>0025-1520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>PFIZER LABORATORIES DIV PFIZER INC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19981002</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CELEBREX is indicated.</IndicationAndUsage>
<Description>CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0025-1520-31</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0025-1520-31) </PackageDescription>
<NDC11Code>00025-1520-31</NDC11Code>
<ProductNDC>0025-1520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>PFIZER LABORATORIES DIV PFIZER INC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19981002</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CELEBREX is indicated.</IndicationAndUsage>
<Description>CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0025-1520-34</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0025-1520-34) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00025-1520-34</NDC11Code>
<ProductNDC>0025-1520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>PFIZER LABORATORIES DIV PFIZER INC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19981002</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CELEBREX is indicated.</IndicationAndUsage>
<Description>CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
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<NDC>
<NDCCode>0025-0061-51</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0025-0061-51)</PackageDescription>
<NDC11Code>00025-0061-51</NDC11Code>
<ProductNDC>0025-0061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lomotil</ProprietaryName>
<NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19600915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012462</ApplicationNumber>
<LabelerName>G.D. Searle LLC Division of Pfizer Inc</LabelerName>
<SubstanceName>ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.025; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-10-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>0025-1381-51</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0025-1381-51) </PackageDescription>
<NDC11Code>00025-1381-51</NDC11Code>
<ProductNDC>0025-1381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daypro</ProprietaryName>
<NonProprietaryName>Oxaprozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018841</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>OXAPROZIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19921029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0025-1525-51</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0025-1525-51) </PackageDescription>
<NDC11Code>00025-1525-51</NDC11Code>
<ProductNDC>0025-1525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>PFIZER LABORATORIES DIV PFIZER INC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19981002</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CELEBREX is indicated.</IndicationAndUsage>
<Description>CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0025-1891-51</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0025-1891-51) </PackageDescription>
<NDC11Code>00025-1891-51</NDC11Code>
<ProductNDC>0025-1891</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calan Sr</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861216</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019152</ApplicationNumber>
<LabelerName>G.D. Searle LLC Division of Pfizer Inc</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861216</StartMarketingDatePackage>
<EndMarketingDatePackage>20190131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0025-2732-51</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-51)</PackageDescription>
<NDC11Code>00025-2732-51</NDC11Code>
<ProductNDC>0025-2732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpace Cr</ProprietaryName>
<NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19820720</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018655</ApplicationNumber>
<LabelerName>G.D. Searle LLC Division of Pfizer Inc</LabelerName>
<SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0025-2742-51</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2742-51)</PackageDescription>
<NDC11Code>00025-2742-51</NDC11Code>
<ProductNDC>0025-2742</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpace Cr</ProprietaryName>
<NonProprietaryName>Disopyramide Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19820720</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018655</ApplicationNumber>
<LabelerName>G.D. Searle LLC Division of Pfizer Inc</LabelerName>
<SubstanceName>DISOPYRAMIDE PHOSPHATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>81033-025-51</NDCCode>
<PackageDescription>5 TUBE in 1 CARTON (81033-025-51) / 5 g in 1 TUBE (81033-025-05) </PackageDescription>
<NDC11Code>81033-0025-51</NDC11Code>
<ProductNDC>81033-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Prilocaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212482</ApplicationNumber>
<LabelerName>Kesin Pharma Corporation</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on. normal intact skinfor local analgesia. genital mucous membranesfor superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and Prilocaine Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).</IndicationAndUsage>
<Description>DESCRIPTION. Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 1 and 5 gram Unit Dose tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. C 14H 22N 2O M.W. 234.3. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. C 13H 20N 2O M.W. 220.3. Each gram of Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, PEG-60 hydrogenated castor oil (as emulsifier), carbomer homopolymer Type B (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and Prilocaine Cream, USP 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of Lidocaine and Prilocaine Cream is 1.00.</Description>
</NDC>
<NDC>
<NDCCode>82442-025-51</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82442-025-51) / 51 g in 1 TUBE</PackageDescription>
<NDC11Code>82442-0025-51</NDC11Code>
<ProductNDC>82442-025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Hemorrhoid Max Strength</ProprietaryName>
<NonProprietaryName>14.4% Glycerin, 0.25% Phenylephrine Hcl, 1% Pramoxine Hcl, 15% Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM</SubstanceName>
<StrengthNumber>144; 2.5; 10; 150</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0025-0325-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0025-0325-01) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>00025-0325-01</NDC11Code>
<ProductNDC>0025-0325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0025-0325-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0025-0325-02) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>00025-0325-02</NDC11Code>
<ProductNDC>0025-0325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0025-0328-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0025-0328-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0025-0317-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>00025-0328-02</NDC11Code>
<ProductNDC>0025-0328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<PackageDescription>2 KIT in 1 CARTON (0025-0333-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (0025-0329-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
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<IndicationAndUsage>ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>Temporarily relieves pain, soreness and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Exelixis, Inc.</LabelerName>
<SubstanceName>CABOZANTINIB S-MALATE</SubstanceName>
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<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).</IndicationAndUsage>
<Description>CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.</Description>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).</IndicationAndUsage>
<Description>CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.</Description>
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<NDC>
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<ProductNDC>42388-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2025-10-23</LastUpdate>
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<IndicationAndUsage>CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).</IndicationAndUsage>
<Description>CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.</Description>
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<IndicationAndUsage>CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).</IndicationAndUsage>
<Description>CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.</Description>
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<IndicationAndUsage>ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<PackageDescription>1 KIT in 1 KIT (50090-8032-0) * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0025-0317-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>50090-8032-00</NDC11Code>
<ProductNDC>50090-8032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABRILADA 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 adult patients. (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 adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA 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 ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. 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 ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 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 ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 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 ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>55490-025-01</NDCCode>
<PackageDescription>5 CLOTH in 1 PACKET (55490-025-01) </PackageDescription>
<NDC11Code>55490-0025-01</NDC11Code>
<ProductNDC>55490-025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>75% Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200910</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Baijieyuan Biotechnology (Shandong) Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>mL/51</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83860-025-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (83860-025-01) </PackageDescription>
<NDC11Code>83860-0025-01</NDC11Code>
<ProductNDC>83860-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vykat Xr</ProprietaryName>
<NonProprietaryName>Diazoxide Choline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216665</ApplicationNumber>
<LabelerName>Soleno Therapeutics, Inc.</LabelerName>
<SubstanceName>DIAZOXIDE CHOLINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).</IndicationAndUsage>
<Description>VYKAT XR contains diazoxide choline. Diazoxide choline is very slightly soluble to soluble in solvents dichloromethane, tetrahydrofuran, acetonitrile, and methanol and practically insoluble in solvents methyl tert-butyl ether. The pKa is 8.44 ± 0.01. Diazoxide choline is 7-Chloro-3-methyl-1λ6, 2,4-benzothiadiazin-2-ide 1,1-dioxide 2- hydroxyethyl(trimethyl)azanium. The empirical formula is C8H6ClN2O2SC5H14NO and the molecular weight is 333.83 g/mole. The structural formula is. VYKAT XR is for oral administration and is available as extended-release tablets in the following strengths: 25 mg tablet contains diazoxide choline 25 mg, equivalent to 17.2 mg diazoxide; 75 mg tablet contains diazoxide choline 75 mg, equivalent to 51.6 mg diazoxide; and 150 mg tablet contains diazoxide choline 150 mg, equivalent to 103.2 mg diazoxide. Each tablet contains the following inactive ingredients: carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene oxide, silicified microcrystalline cellulose, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0069-1520-68</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0069-1520-68) </PackageDescription>
<NDC11Code>00069-1520-68</NDC11Code>
<ProductNDC>0069-1520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norvasc</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920731</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019787</ApplicationNumber>
<LabelerName>PFIZER LABORATORIES DIV PFIZER INC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920731</StartMarketingDatePackage>
<EndMarketingDatePackage>20271031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1)NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. NORVASC (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0110-1520-01</NDCCode>
<PackageDescription>69000 CAPSULE in 1 DRUM (0110-1520-01) </PackageDescription>
<NDC11Code>00110-1520-01</NDC11Code>
<ProductNDC>0110-1520</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20251112</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Lilly del Caribe, Inc.</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-19</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-NOV-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0268-1520-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-1520-10) </PackageDescription>
<NDC11Code>00268-1520-10</NDC11Code>
<ProductNDC>0268-1520</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Amaranthus Tuberculatus Pollen</ProprietaryName>
<NonProprietaryName>Water Hemp</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AMARANTHUS TUBERCULATUS POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-1520-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-1520-50) </PackageDescription>
<NDC11Code>00268-1520-50</NDC11Code>
<ProductNDC>0268-1520</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Amaranthus Tuberculatus Pollen</ProprietaryName>
<NonProprietaryName>Water Hemp</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AMARANTHUS TUBERCULATUS POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0280-1520-04</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (0280-1520-04) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-1520-04</NDC11Code>
<ProductNDC>0280-1520</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170703</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>325; 7.8; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. · temporarily relieves these symptoms due to a cold. · minor aches and pains · headache · runny nose. · nasal and sinus congestion · sneezing · sore throat. · temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-1520-20</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-1520-20) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-1520-20</NDC11Code>
<ProductNDC>0280-1520</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170703</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>325; 7.8; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. · temporarily relieves these symptoms due to a cold. · minor aches and pains · headache · runny nose. · nasal and sinus congestion · sneezing · sore throat. · temporarily reduces fever.</IndicationAndUsage>
</NDC>
</NDCList>